PATENTED TECHNOLOGY

Clinically provenmore e�ective than pure

silicone gel for reduction ofscar, itch and pain

www.scarless.asia

Leading distributor of medical & diagnostic devices in Singapore & Malaysia

49

Graph 1: Vancouver Scar Scale (VSS) components over study period.

Vascularity (p=0.025)

Pliability (p= 0.022)

Height (p= 0.001)

Pigmentation (p= 0.000)

Evaluation of Dermacyn® ScarLess™ Hydrogel in reducing scar formation post laparotomy gynaecology surgery3

References

Dermacyn® ScarLess™ Hydrogel is clinically proven to be e�ective for reducing old and new scars:

How does Dermacyn® ScarLess™ Hydrogel work

Indication

Using Dermacyn® ScarLess™ Hydrogel

Anti-microbial action that is important as wound with infection can increase risk of abnormal scar formation

Anti-in�ammatory action that can decrease risk of scar formation, but also can relieve scarring symptoms, such as pain or itchiness

Silicone-based hydrogel, which helps to:

• Retain moisture of scar tissue that can prevent formation of abnormal scar formation as a result of uncontrolled collagen formation.

1.

2.

3.

Dermacyn® ScarLess™ Hydrogel is e�ective and well tolerated in the manage-ment of hypertrophic or keloid scars:

Dermacyn® ScarLess™ Hydrogel is developed based onpatented Microcyn® Technology, which has:

PATENTED TECHNOLOGY

For new scars:Used as soon as the wound is healed or stitches have been removed, apply thin layer of Dermacyn® ScarLess™ Hydrogel to allow a protective barrier against bacterial growth

!! Hypertrophic scars commonly arise after burns, surgical incisions or other trauma that extends into the reticular dermis. Once formed, there may be partial or complete resolution, or they may remain permanently (Ahn, 1991).

!! Keloid scarring is caused by the growth of dense fibrous tissue that develops from an abnormal healing response to a cutaneous injury, extending beyond the original borders of the wound (Brissett, 2001).

!! Scarring can cause functional, cosmetic and psychological morbidity (Bock, 2006).

!! The clinical symptoms of scars include tenderness, discoloration, pruritus and disfigurement.

!! Treatments for scars include surgery, laser therapy, steroid injections and topical products, such as onion extract gel and silicon gel.

!! Microcyn scar gel was developed to improve the appearance of scars and relieve the itching and pain associated with scars.

!! Microcyn® Technology products are based on the stabilization of hypochlorous acid. The hypochlorous acid in Microcyn Technology is similar to the natural hypochlorous acid produced by the human body. The gel and liquid products are non-irritating, non-sensitizing and non-toxic.

!! Randomized, double-blind, multicenter study !! 56 day (week 8) treatment period with follow up at

day 84 (week 12) and day 112 (week 16) !! Clinic visits and photos on Days 0, 14, 28, 56, 84 and

112

!! Patients: Adults with a linear or widespread hypertrophic or keloid scar

!! Target scar must result from a wound that had healed 3 to 12 months earlier.

!! Target scar must have a minimum total Vancouver Scar Scale (VSS) of 3 out of 9

!! Treatment: Subjects randomized 1:1 to Microcyn scar gel or the comparator device, 100% silicone gel.

!! Medication (1.5 oz tube) dispensed on Days 0, 14 and 28 (3 tubes)

!! Subjects applied treatment three times daily, 8 hrs apart for 8 weeks

!! Endpoints:

!! Vancouver Scar Scale (VSS) assessment at each visit !! Vascularity (normal=0, pink=1, red=2, purple=3) !! Pliability (normal=0, supple=1, yielding=2, firm=3)

!! Height (flat=0, <2mm=1, 2-5mm=2, >5mm=3)

!! Subject-Rated Pain and Itch Assessment at each visit !! Pain (none=0, intermittent=1, moderate=2, severe=3) !! Itch (none=0, intermittent=1, moderate=2, severe=3)

!! Investigator-assessed Subject Global Satisfaction !! At Day 56 and Day 112

!! very good, good, moderate or unsatisfactory

!! Investigator Global Assessment (IGA) of Efficacy !! At week 8, week 12, and week 16 !! very good, good, moderate or unsatisfactory

!! Safety: !! Adverse events (AE) were collected at all visits

!! AEs were rated, graded, and coded based on CTCAE and MedDRA

Baseline Characteristics !!44 adults enrolled at 4 clinical sites in the US

!! 16 male, 28 female ! Mean age 37.3 (range: 18-65) years !!Cause of Scar:

!! Burn (6.8%)

!! Surgery (52.3%) !! Injury (34.1%)

!! Other (6.8%)

!!Age of Scar: !! 3-6 months (36.4%)

!! 6-9 months (31.8%)

!! 9-12 months (31.8%) !!Baseline characteristics were similar between treatment groups.

Improvement in Appearance and Symptoms

This randomized, double-blind study compared the efficacy, safety and tolerability of a Microcyn® Technology scar gel with that of a comparator, 100% silicone gel, for the management of hypertrophic or keloid scars.

A Double-blind, Randomized Study of a Microcyn® Technology Scar Gel In Comparison with 100% Silicone Gel for Hypertrophic or Keloid Scars

Alicia D. Bucko, DO, CPI, JD Academic Dermatology Associates, Albuquerque, NM; Zoe Draelos, MD, Dermatology Consulting Services, High Point, NC; Janet C. Dubois, MD, DermResearch, Inc. Austin, TX; Terry M. Jones, MD, J&S Studies, Inc. College Station, TX

!! This randomized, double blind study demonstrated greater improvements in VSS scores for vascularity, pliability and height of scars with Microcyn scar gel compared with 100% silicone gel at Day 56, Day 84, and Day 112.

!! The Investigator assessment of efficacy was good or very good in 55% of subjects on Microcyn scar gel compared with 28% of subjects on comparator at the end-of-study visit.

!! Overall Microcyn scar gel performed better than the comparator gel for the management of hypertrophic or keloid scars. Both treatments were well tolerated.

Poster presented at the 14th Annual Caribbean Dermatology Symposium, January 20-24, 2015, in St. Maarten

!! The authors gratefully acknowledge Joanna Peterkin, MD; Catherine Schmidt; Brian Martin, Antoinette Douglas, Kristina Thompson; Agility Clinical; Sure Clinical eTMF; and our study coordinators for their important contributions and dedicated work throughout this study.

Introduction

Summary

Methods

Photographic Results: Microcyn Scar Gel Results

Acknowledgements

Purpose

Vancouver Scar Scale (VSS) !! The vascularity, pliability, and height of target scars, improved

consistently over the course of the study. !! At Day 56, the mean total VSS had decreased with Microcyn scar

gel by 2.10 vs. 1.28 with the comparator. !! This improvement continued to the end-of-study visit (week 16)

reaching decreases with Microcyn scar gel of -2.70 vs. -1.83 in the comparator group.

!! The reductions in mean total VSS were greater in the Microcyn scar gel group than those in the comparator group.

Subject-rated pain and itch assessment !! Pain and itch decreased (improved) in both groups with greater

improvement with Microcyn scar gel

Investigator global assessment (IGA) !! The IGA of efficacy was good/very good in 6 (30%) subjects at Day

56 and 11 (55%) subjects at Day 112 with Microcyn scar gel.

!! This compares favorably with 5 (28%) subjects at both time points with the comparator.

Subject Global Satisfaction !! Subject Global Satisfaction was similar between treatment groups

and at various time points.

Safety !! Adverse events (AE) were reported in 4 (18%) of subjects on

Microcyn scar gel and 7 (35%) on the comparator.

!! The Investigator rated the majority of AEs as mild to moderate. !!None of the AEs in the Microcyn scar gel group were related to

treatment. One AE in the comparator group was related to treatment (application site warmth).

!!Most AEs were categorized as infections & infestations and gastrointestinal disorders not associated with treatment.

!!No TEAE occurred in more than one subject in a treatment group.

!!One SAE (rectal perforation) occurred in the Microcyn group that was not related to treatment.

!! Both treatments were well tolerated.

Funding provided by

03-004 White female with linear hypertrophic scar ((6-9 months old) on her left hand due to a burn (Baseline and 16 weeks)

01-007 White female with a keloid (6-9 months old) on her left arm due to surgery (Baseline and 16 weeks)

04-011 White female with linear hypertrophic scar (3-6 months old) due to surgery on left lower leg (Baseline and 16 weeks)

03-011 White female with a linear hypertrophic scar (3-6 months old) on her left arm due to injury (Baseline and 16 weeks)

Percent Improvement Over Baseline

at Week 12

!! Scar type: !! Linear hypertrophic (43.2%)

!! Widespread hypertrophic (9.1%) !! Keloid (50%)

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For older scars: Dermacyn® ScarLess™ Hydrogel can be used immediately. It is important to be consistent in the application for optimum result.

!! Hypertrophic scars commonly arise after burns, surgical incisions or other trauma that extends into the reticular dermis. Once formed, there may be partial or complete resolution, or they may remain permanently (Ahn, 1991).

!! Keloid scarring is caused by the growth of dense fibrous tissue that develops from an abnormal healing response to a cutaneous injury, extending beyond the original borders of the wound (Brissett, 2001).

!! Scarring can cause functional, cosmetic and psychological morbidity (Bock, 2006).

!! The clinical symptoms of scars include tenderness, discoloration, pruritus and disfigurement.

!! Treatments for scars include surgery, laser therapy, steroid injections and topical products, such as onion extract gel and silicon gel.

!! Microcyn scar gel was developed to improve the appearance of scars and relieve the itching and pain associated with scars.

!! Microcyn® Technology products are based on the stabilization of hypochlorous acid. The hypochlorous acid in Microcyn Technology is similar to the natural hypochlorous acid produced by the human body. The gel and liquid products are non-irritating, non-sensitizing and non-toxic.

!! Randomized, double-blind, multicenter study !! 56 day (week 8) treatment period with follow up at

day 84 (week 12) and day 112 (week 16) !! Clinic visits and photos on Days 0, 14, 28, 56, 84 and

112

!! Patients: Adults with a linear or widespread hypertrophic or keloid scar

!! Target scar must result from a wound that had healed 3 to 12 months earlier.

!! Target scar must have a minimum total Vancouver Scar Scale (VSS) of 3 out of 9

!! Treatment: Subjects randomized 1:1 to Microcyn scar gel or the comparator device, 100% silicone gel.

!! Medication (1.5 oz tube) dispensed on Days 0, 14 and 28 (3 tubes)

!! Subjects applied treatment three times daily, 8 hrs apart for 8 weeks

!! Endpoints:

!! Vancouver Scar Scale (VSS) assessment at each visit !! Vascularity (normal=0, pink=1, red=2, purple=3) !! Pliability (normal=0, supple=1, yielding=2, firm=3)

!! Height (flat=0, <2mm=1, 2-5mm=2, >5mm=3)

!! Subject-Rated Pain and Itch Assessment at each visit !! Pain (none=0, intermittent=1, moderate=2, severe=3) !! Itch (none=0, intermittent=1, moderate=2, severe=3)

!! Investigator-assessed Subject Global Satisfaction !! At Day 56 and Day 112

!! very good, good, moderate or unsatisfactory

!! Investigator Global Assessment (IGA) of Efficacy !! At week 8, week 12, and week 16 !! very good, good, moderate or unsatisfactory

!! Safety: !! Adverse events (AE) were collected at all visits

!! AEs were rated, graded, and coded based on CTCAE and MedDRA

Baseline Characteristics !!44 adults enrolled at 4 clinical sites in the US

!! 16 male, 28 female ! Mean age 37.3 (range: 18-65) years !!Cause of Scar:

!! Burn (6.8%)

!! Surgery (52.3%) !! Injury (34.1%)

!! Other (6.8%)

!!Age of Scar: !! 3-6 months (36.4%)

!! 6-9 months (31.8%)

!! 9-12 months (31.8%) !!Baseline characteristics were similar between treatment groups.

Improvement in Appearance and Symptoms

This randomized, double-blind study compared the efficacy, safety and tolerability of a Microcyn® Technology scar gel with that of a comparator, 100% silicone gel, for the management of hypertrophic or keloid scars.

A Double-blind, Randomized Study of a Microcyn® Technology Scar Gel In Comparison with 100% Silicone Gel for Hypertrophic or Keloid Scars

Alicia D. Bucko, DO, CPI, JD Academic Dermatology Associates, Albuquerque, NM; Zoe Draelos, MD, Dermatology Consulting Services, High Point, NC; Janet C. Dubois, MD, DermResearch, Inc. Austin, TX; Terry M. Jones, MD, J&S Studies, Inc. College Station, TX

!! This randomized, double blind study demonstrated greater improvements in VSS scores for vascularity, pliability and height of scars with Microcyn scar gel compared with 100% silicone gel at Day 56, Day 84, and Day 112.

!! The Investigator assessment of efficacy was good or very good in 55% of subjects on Microcyn scar gel compared with 28% of subjects on comparator at the end-of-study visit.

!! Overall Microcyn scar gel performed better than the comparator gel for the management of hypertrophic or keloid scars. Both treatments were well tolerated.

Poster presented at the 14th Annual Caribbean Dermatology Symposium, January 20-24, 2015, in St. Maarten

!! The authors gratefully acknowledge Joanna Peterkin, MD; Catherine Schmidt; Brian Martin, Antoinette Douglas, Kristina Thompson; Agility Clinical; Sure Clinical eTMF; and our study coordinators for their important contributions and dedicated work throughout this study.

Introduction

Summary

Methods

Photographic Results: Microcyn Scar Gel Results

Acknowledgements

Purpose

Vancouver Scar Scale (VSS) !! The vascularity, pliability, and height of target scars, improved

consistently over the course of the study. !! At Day 56, the mean total VSS had decreased with Microcyn scar

gel by 2.10 vs. 1.28 with the comparator. !! This improvement continued to the end-of-study visit (week 16)

reaching decreases with Microcyn scar gel of -2.70 vs. -1.83 in the comparator group.

!! The reductions in mean total VSS were greater in the Microcyn scar gel group than those in the comparator group.

Subject-rated pain and itch assessment !! Pain and itch decreased (improved) in both groups with greater

improvement with Microcyn scar gel

Investigator global assessment (IGA) !! The IGA of efficacy was good/very good in 6 (30%) subjects at Day

56 and 11 (55%) subjects at Day 112 with Microcyn scar gel.

!! This compares favorably with 5 (28%) subjects at both time points with the comparator.

Subject Global Satisfaction !! Subject Global Satisfaction was similar between treatment groups

and at various time points.

Safety !! Adverse events (AE) were reported in 4 (18%) of subjects on

Microcyn scar gel and 7 (35%) on the comparator.

!! The Investigator rated the majority of AEs as mild to moderate. !!None of the AEs in the Microcyn scar gel group were related to

treatment. One AE in the comparator group was related to treatment (application site warmth).

!!Most AEs were categorized as infections & infestations and gastrointestinal disorders not associated with treatment.

!!No TEAE occurred in more than one subject in a treatment group.

!!One SAE (rectal perforation) occurred in the Microcyn group that was not related to treatment.

!! Both treatments were well tolerated.

Funding provided by

03-004 White female with linear hypertrophic scar ((6-9 months old) on her left hand due to a burn (Baseline and 16 weeks)

01-007 White female with a keloid (6-9 months old) on her left arm due to surgery (Baseline and 16 weeks)

04-011 White female with linear hypertrophic scar (3-6 months old) due to surgery on left lower leg (Baseline and 16 weeks)

03-011 White female with a linear hypertrophic scar (3-6 months old) on her left arm due to injury (Baseline and 16 weeks)

Percent Improvement Over Baseline

at Week 12

!! Scar type: !! Linear hypertrophic (43.2%)

!! Widespread hypertrophic (9.1%) !! Keloid (50%)

����������������

How to use Dermacyn® ScarLess™ Hydrogel

!! Hypertrophic scars commonly arise after burns, surgical incisions or other trauma that extends into the reticular dermis. Once formed, there may be partial or complete resolution, or they may remain permanently (Ahn, 1991).

!! Keloid scarring is caused by the growth of dense fibrous tissue that develops from an abnormal healing response to a cutaneous injury, extending beyond the original borders of the wound (Brissett, 2001).

!! Scarring can cause functional, cosmetic and psychological morbidity (Bock, 2006).

!! The clinical symptoms of scars include tenderness, discoloration, pruritus and disfigurement.

!! Treatments for scars include surgery, laser therapy, steroid injections and topical products, such as onion extract gel and silicon gel.

!! Microcyn scar gel was developed to improve the appearance of scars and relieve the itching and pain associated with scars.

!! Microcyn® Technology products are based on the stabilization of hypochlorous acid. The hypochlorous acid in Microcyn Technology is similar to the natural hypochlorous acid produced by the human body. The gel and liquid products are non-irritating, non-sensitizing and non-toxic.

!! Randomized, double-blind, multicenter study !! 56 day (week 8) treatment period with follow up at

day 84 (week 12) and day 112 (week 16) !! Clinic visits and photos on Days 0, 14, 28, 56, 84 and

112

!! Patients: Adults with a linear or widespread hypertrophic or keloid scar

!! Target scar must result from a wound that had healed 3 to 12 months earlier.

!! Target scar must have a minimum total Vancouver Scar Scale (VSS) of 3 out of 9

!! Treatment: Subjects randomized 1:1 to Microcyn scar gel or the comparator device, 100% silicone gel.

!! Medication (1.5 oz tube) dispensed on Days 0, 14 and 28 (3 tubes)

!! Subjects applied treatment three times daily, 8 hrs apart for 8 weeks

!! Endpoints:

!! Vancouver Scar Scale (VSS) assessment at each visit !! Vascularity (normal=0, pink=1, red=2, purple=3) !! Pliability (normal=0, supple=1, yielding=2, firm=3)

!! Height (flat=0, <2mm=1, 2-5mm=2, >5mm=3)

!! Subject-Rated Pain and Itch Assessment at each visit !! Pain (none=0, intermittent=1, moderate=2, severe=3) !! Itch (none=0, intermittent=1, moderate=2, severe=3)

!! Investigator-assessed Subject Global Satisfaction !! At Day 56 and Day 112

!! very good, good, moderate or unsatisfactory

!! Investigator Global Assessment (IGA) of Efficacy !! At week 8, week 12, and week 16 !! very good, good, moderate or unsatisfactory

!! Safety: !! Adverse events (AE) were collected at all visits

!! AEs were rated, graded, and coded based on CTCAE and MedDRA

Baseline Characteristics !!44 adults enrolled at 4 clinical sites in the US

!! 16 male, 28 female ! Mean age 37.3 (range: 18-65) years !!Cause of Scar:

!! Burn (6.8%)

!! Surgery (52.3%) !! Injury (34.1%)

!! Other (6.8%)

!!Age of Scar: !! 3-6 months (36.4%)

!! 6-9 months (31.8%)

!! 9-12 months (31.8%) !!Baseline characteristics were similar between treatment groups.

Improvement in Appearance and Symptoms

This randomized, double-blind study compared the efficacy, safety and tolerability of a Microcyn® Technology scar gel with that of a comparator, 100% silicone gel, for the management of hypertrophic or keloid scars.

A Double-blind, Randomized Study of a Microcyn® Technology Scar Gel In Comparison with 100% Silicone Gel for Hypertrophic or Keloid Scars

Alicia D. Bucko, DO, CPI, JD Academic Dermatology Associates, Albuquerque, NM; Zoe Draelos, MD, Dermatology Consulting Services, High Point, NC; Janet C. Dubois, MD, DermResearch, Inc. Austin, TX; Terry M. Jones, MD, J&S Studies, Inc. College Station, TX

!! This randomized, double blind study demonstrated greater improvements in VSS scores for vascularity, pliability and height of scars with Microcyn scar gel compared with 100% silicone gel at Day 56, Day 84, and Day 112.

!! The Investigator assessment of efficacy was good or very good in 55% of subjects on Microcyn scar gel compared with 28% of subjects on comparator at the end-of-study visit.

!! Overall Microcyn scar gel performed better than the comparator gel for the management of hypertrophic or keloid scars. Both treatments were well tolerated.

Poster presented at the 14th Annual Caribbean Dermatology Symposium, January 20-24, 2015, in St. Maarten

!! The authors gratefully acknowledge Joanna Peterkin, MD; Catherine Schmidt; Brian Martin, Antoinette Douglas, Kristina Thompson; Agility Clinical; Sure Clinical eTMF; and our study coordinators for their important contributions and dedicated work throughout this study.

Introduction

Summary

Methods

Photographic Results: Microcyn Scar Gel Results

Acknowledgements

Purpose

Vancouver Scar Scale (VSS) !! The vascularity, pliability, and height of target scars, improved

consistently over the course of the study. !! At Day 56, the mean total VSS had decreased with Microcyn scar

gel by 2.10 vs. 1.28 with the comparator. !! This improvement continued to the end-of-study visit (week 16)

reaching decreases with Microcyn scar gel of -2.70 vs. -1.83 in the comparator group.

!! The reductions in mean total VSS were greater in the Microcyn scar gel group than those in the comparator group.

Subject-rated pain and itch assessment !! Pain and itch decreased (improved) in both groups with greater

improvement with Microcyn scar gel

Investigator global assessment (IGA) !! The IGA of efficacy was good/very good in 6 (30%) subjects at Day

56 and 11 (55%) subjects at Day 112 with Microcyn scar gel.

!! This compares favorably with 5 (28%) subjects at both time points with the comparator.

Subject Global Satisfaction !! Subject Global Satisfaction was similar between treatment groups

and at various time points.

Safety !! Adverse events (AE) were reported in 4 (18%) of subjects on

Microcyn scar gel and 7 (35%) on the comparator.

!! The Investigator rated the majority of AEs as mild to moderate. !!None of the AEs in the Microcyn scar gel group were related to

treatment. One AE in the comparator group was related to treatment (application site warmth).

!!Most AEs were categorized as infections & infestations and gastrointestinal disorders not associated with treatment.

!!No TEAE occurred in more than one subject in a treatment group.

!!One SAE (rectal perforation) occurred in the Microcyn group that was not related to treatment.

!! Both treatments were well tolerated.

Funding provided by

03-004 White female with linear hypertrophic scar ((6-9 months old) on her left hand due to a burn (Baseline and 16 weeks)

01-007 White female with a keloid (6-9 months old) on her left arm due to surgery (Baseline and 16 weeks)

04-011 White female with linear hypertrophic scar (3-6 months old) due to surgery on left lower leg (Baseline and 16 weeks)

03-011 White female with a linear hypertrophic scar (3-6 months old) on her left arm due to injury (Baseline and 16 weeks)

Percent Improvement Over Baseline

at Week 12

!! Scar type: !! Linear hypertrophic (43.2%)

!! Widespread hypertrophic (9.1%) !! Keloid (50%)

!! Hypertrophic scars commonly arise after burns, surgical incisions or other trauma that extends into the reticular dermis. Once formed, there may be partial or complete resolution, or they may remain permanently (Ahn, 1991).

!! Keloid scarring is caused by the growth of dense fibrous tissue that develops from an abnormal healing response to a cutaneous injury, extending beyond the original borders of the wound (Brissett, 2001).

!! Scarring can cause functional, cosmetic and psychological morbidity (Bock, 2006).

!! The clinical symptoms of scars include tenderness, discoloration, pruritus and disfigurement.

!! Treatments for scars include surgery, laser therapy, steroid injections and topical products, such as onion extract gel and silicon gel.

!! Microcyn scar gel was developed to improve the appearance of scars and relieve the itching and pain associated with scars.

!! Microcyn® Technology products are based on the stabilization of hypochlorous acid. The hypochlorous acid in Microcyn Technology is similar to the natural hypochlorous acid produced by the human body. The gel and liquid products are non-irritating, non-sensitizing and non-toxic.

!! Randomized, double-blind, multicenter study !! 56 day (week 8) treatment period with follow up at

day 84 (week 12) and day 112 (week 16) !! Clinic visits and photos on Days 0, 14, 28, 56, 84 and

112

!! Patients: Adults with a linear or widespread hypertrophic or keloid scar

!! Target scar must result from a wound that had healed 3 to 12 months earlier.

!! Target scar must have a minimum total Vancouver Scar Scale (VSS) of 3 out of 9

!! Treatment: Subjects randomized 1:1 to Microcyn scar gel or the comparator device, 100% silicone gel.

!! Medication (1.5 oz tube) dispensed on Days 0, 14 and 28 (3 tubes)

!! Subjects applied treatment three times daily, 8 hrs apart for 8 weeks

!! Endpoints:

!! Vancouver Scar Scale (VSS) assessment at each visit !! Vascularity (normal=0, pink=1, red=2, purple=3) !! Pliability (normal=0, supple=1, yielding=2, firm=3)

!! Height (flat=0, <2mm=1, 2-5mm=2, >5mm=3)

!! Subject-Rated Pain and Itch Assessment at each visit !! Pain (none=0, intermittent=1, moderate=2, severe=3) !! Itch (none=0, intermittent=1, moderate=2, severe=3)

!! Investigator-assessed Subject Global Satisfaction !! At Day 56 and Day 112

!! very good, good, moderate or unsatisfactory

!! Investigator Global Assessment (IGA) of Efficacy !! At week 8, week 12, and week 16 !! very good, good, moderate or unsatisfactory

!! Safety: !! Adverse events (AE) were collected at all visits

!! AEs were rated, graded, and coded based on CTCAE and MedDRA

Baseline Characteristics !!44 adults enrolled at 4 clinical sites in the US

!! 16 male, 28 female ! Mean age 37.3 (range: 18-65) years !!Cause of Scar:

!! Burn (6.8%)

!! Surgery (52.3%) !! Injury (34.1%)

!! Other (6.8%)

!!Age of Scar: !! 3-6 months (36.4%)

!! 6-9 months (31.8%)

!! 9-12 months (31.8%) !!Baseline characteristics were similar between treatment groups.

Improvement in Appearance and Symptoms

This randomized, double-blind study compared the efficacy, safety and tolerability of a Microcyn® Technology scar gel with that of a comparator, 100% silicone gel, for the management of hypertrophic or keloid scars.

A Double-blind, Randomized Study of a Microcyn® Technology Scar Gel In Comparison with 100% Silicone Gel for Hypertrophic or Keloid Scars

Alicia D. Bucko, DO, CPI, JD Academic Dermatology Associates, Albuquerque, NM; Zoe Draelos, MD, Dermatology Consulting Services, High Point, NC; Janet C. Dubois, MD, DermResearch, Inc. Austin, TX; Terry M. Jones, MD, J&S Studies, Inc. College Station, TX

!! This randomized, double blind study demonstrated greater improvements in VSS scores for vascularity, pliability and height of scars with Microcyn scar gel compared with 100% silicone gel at Day 56, Day 84, and Day 112.

!! The Investigator assessment of efficacy was good or very good in 55% of subjects on Microcyn scar gel compared with 28% of subjects on comparator at the end-of-study visit.

!! Overall Microcyn scar gel performed better than the comparator gel for the management of hypertrophic or keloid scars. Both treatments were well tolerated.

Poster presented at the 14th Annual Caribbean Dermatology Symposium, January 20-24, 2015, in St. Maarten

!! The authors gratefully acknowledge Joanna Peterkin, MD; Catherine Schmidt; Brian Martin, Antoinette Douglas, Kristina Thompson; Agility Clinical; Sure Clinical eTMF; and our study coordinators for their important contributions and dedicated work throughout this study.

Introduction

Summary

Methods

Photographic Results: Microcyn Scar Gel Results

Acknowledgements

Purpose

Vancouver Scar Scale (VSS) !! The vascularity, pliability, and height of target scars, improved

consistently over the course of the study. !! At Day 56, the mean total VSS had decreased with Microcyn scar

gel by 2.10 vs. 1.28 with the comparator. !! This improvement continued to the end-of-study visit (week 16)

reaching decreases with Microcyn scar gel of -2.70 vs. -1.83 in the comparator group.

!! The reductions in mean total VSS were greater in the Microcyn scar gel group than those in the comparator group.

Subject-rated pain and itch assessment !! Pain and itch decreased (improved) in both groups with greater

improvement with Microcyn scar gel

Investigator global assessment (IGA) !! The IGA of efficacy was good/very good in 6 (30%) subjects at Day

56 and 11 (55%) subjects at Day 112 with Microcyn scar gel.

!! This compares favorably with 5 (28%) subjects at both time points with the comparator.

Subject Global Satisfaction !! Subject Global Satisfaction was similar between treatment groups

and at various time points.

Safety !! Adverse events (AE) were reported in 4 (18%) of subjects on

Microcyn scar gel and 7 (35%) on the comparator.

!! The Investigator rated the majority of AEs as mild to moderate. !!None of the AEs in the Microcyn scar gel group were related to

treatment. One AE in the comparator group was related to treatment (application site warmth).

!!Most AEs were categorized as infections & infestations and gastrointestinal disorders not associated with treatment.

!!No TEAE occurred in more than one subject in a treatment group.

!!One SAE (rectal perforation) occurred in the Microcyn group that was not related to treatment.

!! Both treatments were well tolerated.

Funding provided by

03-004 White female with linear hypertrophic scar ((6-9 months old) on her left hand due to a burn (Baseline and 16 weeks)

01-007 White female with a keloid (6-9 months old) on her left arm due to surgery (Baseline and 16 weeks)

04-011 White female with linear hypertrophic scar (3-6 months old) due to surgery on left lower leg (Baseline and 16 weeks)

03-011 White female with a linear hypertrophic scar (3-6 months old) on her left arm due to injury (Baseline and 16 weeks)

Percent Improvement Over Baseline

at Week 12

!! Scar type: !! Linear hypertrophic (43.2%)

!! Widespread hypertrophic (9.1%) !! Keloid (50%)

Indication

!! Hypertrophic scars commonly arise after burns, surgical incisions or other trauma that extends into the reticular dermis. Once formed, there may be partial or complete resolution, or they may remain permanently (Ahn, 1991).

!! Keloid scarring is caused by the growth of dense fibrous tissue that develops from an abnormal healing response to a cutaneous injury, extending beyond the original borders of the wound (Brissett, 2001).

!! Scarring can cause functional, cosmetic and psychological morbidity (Bock, 2006).

!! The clinical symptoms of scars include tenderness, discoloration, pruritus and disfigurement.

!! Treatments for scars include surgery, laser therapy, steroid injections and topical products, such as onion extract gel and silicon gel.

!! Microcyn scar gel was developed to improve the appearance of scars and relieve the itching and pain associated with scars.

!! Microcyn® Technology products are based on the stabilization of hypochlorous acid. The hypochlorous acid in Microcyn Technology is similar to the natural hypochlorous acid produced by the human body. The gel and liquid products are non-irritating, non-sensitizing and non-toxic.

!! Randomized, double-blind, multicenter study !! 56 day (week 8) treatment period with follow up at

day 84 (week 12) and day 112 (week 16) !! Clinic visits and photos on Days 0, 14, 28, 56, 84 and

112

!! Patients: Adults with a linear or widespread hypertrophic or keloid scar

!! Target scar must result from a wound that had healed 3 to 12 months earlier.

!! Target scar must have a minimum total Vancouver Scar Scale (VSS) of 3 out of 9

!! Treatment: Subjects randomized 1:1 to Microcyn scar gel or the comparator device, 100% silicone gel.

!! Medication (1.5 oz tube) dispensed on Days 0, 14 and 28 (3 tubes)

!! Subjects applied treatment three times daily, 8 hrs apart for 8 weeks

!! Endpoints:

!! Vancouver Scar Scale (VSS) assessment at each visit !! Vascularity (normal=0, pink=1, red=2, purple=3) !! Pliability (normal=0, supple=1, yielding=2, firm=3)

!! Height (flat=0, <2mm=1, 2-5mm=2, >5mm=3)

!! Subject-Rated Pain and Itch Assessment at each visit !! Pain (none=0, intermittent=1, moderate=2, severe=3) !! Itch (none=0, intermittent=1, moderate=2, severe=3)

!! Investigator-assessed Subject Global Satisfaction !! At Day 56 and Day 112

!! very good, good, moderate or unsatisfactory

!! Investigator Global Assessment (IGA) of Efficacy !! At week 8, week 12, and week 16 !! very good, good, moderate or unsatisfactory

!! Safety: !! Adverse events (AE) were collected at all visits

!! AEs were rated, graded, and coded based on CTCAE and MedDRA

Baseline Characteristics !!44 adults enrolled at 4 clinical sites in the US

!! 16 male, 28 female ! Mean age 37.3 (range: 18-65) years !!Cause of Scar:

!! Burn (6.8%)

!! Surgery (52.3%) !! Injury (34.1%)

!! Other (6.8%)

!!Age of Scar: !! 3-6 months (36.4%)

!! 6-9 months (31.8%)

!! 9-12 months (31.8%) !!Baseline characteristics were similar between treatment groups.

Improvement in Appearance and Symptoms

This randomized, double-blind study compared the efficacy, safety and tolerability of a Microcyn® Technology scar gel with that of a comparator, 100% silicone gel, for the management of hypertrophic or keloid scars.

A Double-blind, Randomized Study of a Microcyn® Technology Scar Gel In Comparison with 100% Silicone Gel for Hypertrophic or Keloid Scars

Alicia D. Bucko, DO, CPI, JD Academic Dermatology Associates, Albuquerque, NM; Zoe Draelos, MD, Dermatology Consulting Services, High Point, NC; Janet C. Dubois, MD, DermResearch, Inc. Austin, TX; Terry M. Jones, MD, J&S Studies, Inc. College Station, TX

!! This randomized, double blind study demonstrated greater improvements in VSS scores for vascularity, pliability and height of scars with Microcyn scar gel compared with 100% silicone gel at Day 56, Day 84, and Day 112.

!! The Investigator assessment of efficacy was good or very good in 55% of subjects on Microcyn scar gel compared with 28% of subjects on comparator at the end-of-study visit.

!! Overall Microcyn scar gel performed better than the comparator gel for the management of hypertrophic or keloid scars. Both treatments were well tolerated.

Poster presented at the 14th Annual Caribbean Dermatology Symposium, January 20-24, 2015, in St. Maarten

!! The authors gratefully acknowledge Joanna Peterkin, MD; Catherine Schmidt; Brian Martin, Antoinette Douglas, Kristina Thompson; Agility Clinical; Sure Clinical eTMF; and our study coordinators for their important contributions and dedicated work throughout this study.

Introduction

Summary

Methods

Photographic Results: Microcyn Scar Gel Results

Acknowledgements

Purpose

Vancouver Scar Scale (VSS) !! The vascularity, pliability, and height of target scars, improved

consistently over the course of the study. !! At Day 56, the mean total VSS had decreased with Microcyn scar

gel by 2.10 vs. 1.28 with the comparator. !! This improvement continued to the end-of-study visit (week 16)

reaching decreases with Microcyn scar gel of -2.70 vs. -1.83 in the comparator group.

!! The reductions in mean total VSS were greater in the Microcyn scar gel group than those in the comparator group.

Subject-rated pain and itch assessment !! Pain and itch decreased (improved) in both groups with greater

improvement with Microcyn scar gel

Investigator global assessment (IGA) !! The IGA of efficacy was good/very good in 6 (30%) subjects at Day

56 and 11 (55%) subjects at Day 112 with Microcyn scar gel.

!! This compares favorably with 5 (28%) subjects at both time points with the comparator.

Subject Global Satisfaction !! Subject Global Satisfaction was similar between treatment groups

and at various time points.

Safety !! Adverse events (AE) were reported in 4 (18%) of subjects on

Microcyn scar gel and 7 (35%) on the comparator.

!! The Investigator rated the majority of AEs as mild to moderate. !!None of the AEs in the Microcyn scar gel group were related to

treatment. One AE in the comparator group was related to treatment (application site warmth).

!!Most AEs were categorized as infections & infestations and gastrointestinal disorders not associated with treatment.

!!No TEAE occurred in more than one subject in a treatment group.

!!One SAE (rectal perforation) occurred in the Microcyn group that was not related to treatment.

!! Both treatments were well tolerated.

Funding provided by

03-004 White female with linear hypertrophic scar ((6-9 months old) on her left hand due to a burn (Baseline and 16 weeks)

01-007 White female with a keloid (6-9 months old) on her left arm due to surgery (Baseline and 16 weeks)

04-011 White female with linear hypertrophic scar (3-6 months old) due to surgery on left lower leg (Baseline and 16 weeks)

03-011 White female with a linear hypertrophic scar (3-6 months old) on her left arm due to injury (Baseline and 16 weeks)

Percent Improvement Over Baseline

at Week 12

!! Scar type: !! Linear hypertrophic (43.2%)

!! Widespread hypertrophic (9.1%) !! Keloid (50%)

!! Hypertrophic scars commonly arise after burns, surgical incisions or other trauma that extends into the reticular dermis. Once formed, there may be partial or complete resolution, or they may remain permanently (Ahn, 1991).

!! Keloid scarring is caused by the growth of dense fibrous tissue that develops from an abnormal healing response to a cutaneous injury, extending beyond the original borders of the wound (Brissett, 2001).

!! Scarring can cause functional, cosmetic and psychological morbidity (Bock, 2006).

!! The clinical symptoms of scars include tenderness, discoloration, pruritus and disfigurement.

!! Treatments for scars include surgery, laser therapy, steroid injections and topical products, such as onion extract gel and silicon gel.

!! Microcyn scar gel was developed to improve the appearance of scars and relieve the itching and pain associated with scars.

!! Microcyn® Technology products are based on the stabilization of hypochlorous acid. The hypochlorous acid in Microcyn Technology is similar to the natural hypochlorous acid produced by the human body. The gel and liquid products are non-irritating, non-sensitizing and non-toxic.

!! Randomized, double-blind, multicenter study !! 56 day (week 8) treatment period with follow up at

day 84 (week 12) and day 112 (week 16) !! Clinic visits and photos on Days 0, 14, 28, 56, 84 and

112

!! Patients: Adults with a linear or widespread hypertrophic or keloid scar

!! Target scar must result from a wound that had healed 3 to 12 months earlier.

!! Target scar must have a minimum total Vancouver Scar Scale (VSS) of 3 out of 9

!! Treatment: Subjects randomized 1:1 to Microcyn scar gel or the comparator device, 100% silicone gel.

!! Medication (1.5 oz tube) dispensed on Days 0, 14 and 28 (3 tubes)

!! Subjects applied treatment three times daily, 8 hrs apart for 8 weeks

!! Endpoints:

!! Vancouver Scar Scale (VSS) assessment at each visit !! Vascularity (normal=0, pink=1, red=2, purple=3) !! Pliability (normal=0, supple=1, yielding=2, firm=3)

!! Height (flat=0, <2mm=1, 2-5mm=2, >5mm=3)

!! Subject-Rated Pain and Itch Assessment at each visit !! Pain (none=0, intermittent=1, moderate=2, severe=3) !! Itch (none=0, intermittent=1, moderate=2, severe=3)

!! Investigator-assessed Subject Global Satisfaction !! At Day 56 and Day 112

!! very good, good, moderate or unsatisfactory

!! Investigator Global Assessment (IGA) of Efficacy !! At week 8, week 12, and week 16 !! very good, good, moderate or unsatisfactory

!! Safety: !! Adverse events (AE) were collected at all visits

!! AEs were rated, graded, and coded based on CTCAE and MedDRA

Baseline Characteristics !!44 adults enrolled at 4 clinical sites in the US

!! 16 male, 28 female ! Mean age 37.3 (range: 18-65) years !!Cause of Scar:

!! Burn (6.8%)

!! Surgery (52.3%) !! Injury (34.1%)

!! Other (6.8%)

!!Age of Scar: !! 3-6 months (36.4%)

!! 6-9 months (31.8%)

!! 9-12 months (31.8%) !!Baseline characteristics were similar between treatment groups.

Improvement in Appearance and Symptoms

This randomized, double-blind study compared the efficacy, safety and tolerability of a Microcyn® Technology scar gel with that of a comparator, 100% silicone gel, for the management of hypertrophic or keloid scars.

A Double-blind, Randomized Study of a Microcyn® Technology Scar Gel In Comparison with 100% Silicone Gel for Hypertrophic or Keloid Scars

Alicia D. Bucko, DO, CPI, JD Academic Dermatology Associates, Albuquerque, NM; Zoe Draelos, MD, Dermatology Consulting Services, High Point, NC; Janet C. Dubois, MD, DermResearch, Inc. Austin, TX; Terry M. Jones, MD, J&S Studies, Inc. College Station, TX

!! This randomized, double blind study demonstrated greater improvements in VSS scores for vascularity, pliability and height of scars with Microcyn scar gel compared with 100% silicone gel at Day 56, Day 84, and Day 112.

!! The Investigator assessment of efficacy was good or very good in 55% of subjects on Microcyn scar gel compared with 28% of subjects on comparator at the end-of-study visit.

!! Overall Microcyn scar gel performed better than the comparator gel for the management of hypertrophic or keloid scars. Both treatments were well tolerated.

Poster presented at the 14th Annual Caribbean Dermatology Symposium, January 20-24, 2015, in St. Maarten

!! The authors gratefully acknowledge Joanna Peterkin, MD; Catherine Schmidt; Brian Martin, Antoinette Douglas, Kristina Thompson; Agility Clinical; Sure Clinical eTMF; and our study coordinators for their important contributions and dedicated work throughout this study.

Introduction

Summary

Methods

Photographic Results: Microcyn Scar Gel Results

Acknowledgements

Purpose

Vancouver Scar Scale (VSS) !! The vascularity, pliability, and height of target scars, improved

consistently over the course of the study. !! At Day 56, the mean total VSS had decreased with Microcyn scar

gel by 2.10 vs. 1.28 with the comparator. !! This improvement continued to the end-of-study visit (week 16)

reaching decreases with Microcyn scar gel of -2.70 vs. -1.83 in the comparator group.

!! The reductions in mean total VSS were greater in the Microcyn scar gel group than those in the comparator group.

Subject-rated pain and itch assessment !! Pain and itch decreased (improved) in both groups with greater

improvement with Microcyn scar gel

Investigator global assessment (IGA) !! The IGA of efficacy was good/very good in 6 (30%) subjects at Day

56 and 11 (55%) subjects at Day 112 with Microcyn scar gel.

!! This compares favorably with 5 (28%) subjects at both time points with the comparator.

Subject Global Satisfaction !! Subject Global Satisfaction was similar between treatment groups

and at various time points.

Safety !! Adverse events (AE) were reported in 4 (18%) of subjects on

Microcyn scar gel and 7 (35%) on the comparator.

!! The Investigator rated the majority of AEs as mild to moderate. !!None of the AEs in the Microcyn scar gel group were related to

treatment. One AE in the comparator group was related to treatment (application site warmth).

!!Most AEs were categorized as infections & infestations and gastrointestinal disorders not associated with treatment.

!!No TEAE occurred in more than one subject in a treatment group.

!!One SAE (rectal perforation) occurred in the Microcyn group that was not related to treatment.

!! Both treatments were well tolerated.

Funding provided by

03-004 White female with linear hypertrophic scar ((6-9 months old) on her left hand due to a burn (Baseline and 16 weeks)

01-007 White female with a keloid (6-9 months old) on her left arm due to surgery (Baseline and 16 weeks)

04-011 White female with linear hypertrophic scar (3-6 months old) due to surgery on left lower leg (Baseline and 16 weeks)

03-011 White female with a linear hypertrophic scar (3-6 months old) on her left arm due to injury (Baseline and 16 weeks)

Percent Improvement Over Baseline

at Week 12

!! Scar type: !! Linear hypertrophic (43.2%)

!! Widespread hypertrophic (9.1%) !! Keloid (50%)

This randomised, double-blind study compared the e�cacy, safety and tolerability of Derma-

cyn® ScarLess™ Hydrogel with that of a comparator, 100% silicone gel, for the management of hypertrophic or keloid scars.

Improvement in Appearance and Symptoms

Overall, Dermacyn® ScarLess™ Hydrogel performed better than the comparator gel for the management of hypertrophic or keloid scars. Both treatments were well tolerated.

Checking Microcyn® Competitor Vascularity 42 % 28 % Pliability 47 % 34 % Height 30 % 11 %

Vancouver 40 % 26 % Pain 100 % 72 % Itch 78 % 70 %

Dermacyn® ScarLess™ Hydrogel is recommended for continuous application over a minimum period of 4 months. Larger scars may take longer to heal.

A Double-blind, Randomized Study of a Microcyn® Technology Scar Gel (ScarlessTM) In Comparison with 100% Silicone Gel for

Hypertrophic or Keloid Scars(Alicia D. et al., 2015)

How to use Dermacyn® ScarLess™ Hydrogel

Step 1 Step 2 Step 3 Step 4

Repeat the application for three times daily.

Gently rub until it is evenly distributed.

Apply a thin layer of Scarless hydrogel.

Wash the a�ected area with clean water with or without soap, then tap

the area dry.

!! Hypertrophic scars commonly arise after burns, surgical incisions or other trauma that extends into the reticular dermis. Once formed, there may be partial or complete resolution, or they may remain permanently (Ahn, 1991).

!! Keloid scarring is caused by the growth of dense fibrous tissue that develops from an abnormal healing response to a cutaneous injury, extending beyond the original borders of the wound (Brissett, 2001).

!! Scarring can cause functional, cosmetic and psychological morbidity (Bock, 2006).

!! The clinical symptoms of scars include tenderness, discoloration, pruritus and disfigurement.

!! Treatments for scars include surgery, laser therapy, steroid injections and topical products, such as onion extract gel and silicon gel.

!! Microcyn scar gel was developed to improve the appearance of scars and relieve the itching and pain associated with scars.

!! Microcyn® Technology products are based on the stabilization of hypochlorous acid. The hypochlorous acid in Microcyn Technology is similar to the natural hypochlorous acid produced by the human body. The gel and liquid products are non-irritating, non-sensitizing and non-toxic.

!! Randomized, double-blind, multicenter study !! 56 day (week 8) treatment period with follow up at

day 84 (week 12) and day 112 (week 16) !! Clinic visits and photos on Days 0, 14, 28, 56, 84 and

112

!! Patients: Adults with a linear or widespread hypertrophic or keloid scar

!! Target scar must result from a wound that had healed 3 to 12 months earlier.

!! Target scar must have a minimum total Vancouver Scar Scale (VSS) of 3 out of 9

!! Treatment: Subjects randomized 1:1 to Microcyn scar gel or the comparator device, 100% silicone gel.

!! Medication (1.5 oz tube) dispensed on Days 0, 14 and 28 (3 tubes)

!! Subjects applied treatment three times daily, 8 hrs apart for 8 weeks

!! Endpoints:

!! Vancouver Scar Scale (VSS) assessment at each visit !! Vascularity (normal=0, pink=1, red=2, purple=3) !! Pliability (normal=0, supple=1, yielding=2, firm=3)

!! Height (flat=0, <2mm=1, 2-5mm=2, >5mm=3)

!! Subject-Rated Pain and Itch Assessment at each visit !! Pain (none=0, intermittent=1, moderate=2, severe=3) !! Itch (none=0, intermittent=1, moderate=2, severe=3)

!! Investigator-assessed Subject Global Satisfaction !! At Day 56 and Day 112

!! very good, good, moderate or unsatisfactory

!! Investigator Global Assessment (IGA) of Efficacy !! At week 8, week 12, and week 16 !! very good, good, moderate or unsatisfactory

!! Safety: !! Adverse events (AE) were collected at all visits

!! AEs were rated, graded, and coded based on CTCAE and MedDRA

Baseline Characteristics !!44 adults enrolled at 4 clinical sites in the US

!! 16 male, 28 female ! Mean age 37.3 (range: 18-65) years !!Cause of Scar:

!! Burn (6.8%)

!! Surgery (52.3%) !! Injury (34.1%)

!! Other (6.8%)

!!Age of Scar: !! 3-6 months (36.4%)

!! 6-9 months (31.8%)

!! 9-12 months (31.8%) !!Baseline characteristics were similar between treatment groups.

Improvement in Appearance and Symptoms

This randomized, double-blind study compared the efficacy, safety and tolerability of a Microcyn® Technology scar gel with that of a comparator, 100% silicone gel, for the management of hypertrophic or keloid scars.

A Double-blind, Randomized Study of a Microcyn® Technology Scar Gel In Comparison with 100% Silicone Gel for Hypertrophic or Keloid Scars

Alicia D. Bucko, DO, CPI, JD Academic Dermatology Associates, Albuquerque, NM; Zoe Draelos, MD, Dermatology Consulting Services, High Point, NC; Janet C. Dubois, MD, DermResearch, Inc. Austin, TX; Terry M. Jones, MD, J&S Studies, Inc. College Station, TX

!! This randomized, double blind study demonstrated greater improvements in VSS scores for vascularity, pliability and height of scars with Microcyn scar gel compared with 100% silicone gel at Day 56, Day 84, and Day 112.

!! The Investigator assessment of efficacy was good or very good in 55% of subjects on Microcyn scar gel compared with 28% of subjects on comparator at the end-of-study visit.

!! Overall Microcyn scar gel performed better than the comparator gel for the management of hypertrophic or keloid scars. Both treatments were well tolerated.

Poster presented at the 14th Annual Caribbean Dermatology Symposium, January 20-24, 2015, in St. Maarten

!! The authors gratefully acknowledge Joanna Peterkin, MD; Catherine Schmidt; Brian Martin, Antoinette Douglas, Kristina Thompson; Agility Clinical; Sure Clinical eTMF; and our study coordinators for their important contributions and dedicated work throughout this study.

Introduction

Summary

Methods

Photographic Results: Microcyn Scar Gel Results

Acknowledgements

Purpose

Vancouver Scar Scale (VSS) !! The vascularity, pliability, and height of target scars, improved

consistently over the course of the study. !! At Day 56, the mean total VSS had decreased with Microcyn scar

gel by 2.10 vs. 1.28 with the comparator. !! This improvement continued to the end-of-study visit (week 16)

reaching decreases with Microcyn scar gel of -2.70 vs. -1.83 in the comparator group.

!! The reductions in mean total VSS were greater in the Microcyn scar gel group than those in the comparator group.

Subject-rated pain and itch assessment !! Pain and itch decreased (improved) in both groups with greater

improvement with Microcyn scar gel

Investigator global assessment (IGA) !! The IGA of efficacy was good/very good in 6 (30%) subjects at Day

56 and 11 (55%) subjects at Day 112 with Microcyn scar gel.

!! This compares favorably with 5 (28%) subjects at both time points with the comparator.

Subject Global Satisfaction !! Subject Global Satisfaction was similar between treatment groups

and at various time points.

Safety !! Adverse events (AE) were reported in 4 (18%) of subjects on

Microcyn scar gel and 7 (35%) on the comparator.

!! The Investigator rated the majority of AEs as mild to moderate. !!None of the AEs in the Microcyn scar gel group were related to

treatment. One AE in the comparator group was related to treatment (application site warmth).

!!Most AEs were categorized as infections & infestations and gastrointestinal disorders not associated with treatment.

!!No TEAE occurred in more than one subject in a treatment group.

!!One SAE (rectal perforation) occurred in the Microcyn group that was not related to treatment.

!! Both treatments were well tolerated.

Funding provided by

03-004 White female with linear hypertrophic scar ((6-9 months old) on her left hand due to a burn (Baseline and 16 weeks)

01-007 White female with a keloid (6-9 months old) on her left arm due to surgery (Baseline and 16 weeks)

04-011 White female with linear hypertrophic scar (3-6 months old) due to surgery on left lower leg (Baseline and 16 weeks)

03-011 White female with a linear hypertrophic scar (3-6 months old) on her left arm due to injury (Baseline and 16 weeks)

Percent Improvement Over Baseline

at Week 12

!! Scar type: !! Linear hypertrophic (43.2%)

!! Widespread hypertrophic (9.1%) !! Keloid (50%)

!! Hypertrophic scars commonly arise after burns, surgical incisions or other trauma that extends into the reticular dermis. Once formed, there may be partial or complete resolution, or they may remain permanently (Ahn, 1991).

!! Keloid scarring is caused by the growth of dense fibrous tissue that develops from an abnormal healing response to a cutaneous injury, extending beyond the original borders of the wound (Brissett, 2001).

!! Scarring can cause functional, cosmetic and psychological morbidity (Bock, 2006).

!! The clinical symptoms of scars include tenderness, discoloration, pruritus and disfigurement.

!! Treatments for scars include surgery, laser therapy, steroid injections and topical products, such as onion extract gel and silicon gel.

!! Microcyn scar gel was developed to improve the appearance of scars and relieve the itching and pain associated with scars.

!! Microcyn® Technology products are based on the stabilization of hypochlorous acid. The hypochlorous acid in Microcyn Technology is similar to the natural hypochlorous acid produced by the human body. The gel and liquid products are non-irritating, non-sensitizing and non-toxic.

!! Randomized, double-blind, multicenter study !! 56 day (week 8) treatment period with follow up at

day 84 (week 12) and day 112 (week 16) !! Clinic visits and photos on Days 0, 14, 28, 56, 84 and

112

!! Patients: Adults with a linear or widespread hypertrophic or keloid scar

!! Target scar must result from a wound that had healed 3 to 12 months earlier.

!! Target scar must have a minimum total Vancouver Scar Scale (VSS) of 3 out of 9

!! Treatment: Subjects randomized 1:1 to Microcyn scar gel or the comparator device, 100% silicone gel.

!! Medication (1.5 oz tube) dispensed on Days 0, 14 and 28 (3 tubes)

!! Subjects applied treatment three times daily, 8 hrs apart for 8 weeks

!! Endpoints:

!! Vancouver Scar Scale (VSS) assessment at each visit !! Vascularity (normal=0, pink=1, red=2, purple=3) !! Pliability (normal=0, supple=1, yielding=2, firm=3)

!! Height (flat=0, <2mm=1, 2-5mm=2, >5mm=3)

!! Subject-Rated Pain and Itch Assessment at each visit !! Pain (none=0, intermittent=1, moderate=2, severe=3) !! Itch (none=0, intermittent=1, moderate=2, severe=3)

!! Investigator-assessed Subject Global Satisfaction !! At Day 56 and Day 112

!! very good, good, moderate or unsatisfactory

!! Investigator Global Assessment (IGA) of Efficacy !! At week 8, week 12, and week 16 !! very good, good, moderate or unsatisfactory

!! Safety: !! Adverse events (AE) were collected at all visits

!! AEs were rated, graded, and coded based on CTCAE and MedDRA

Baseline Characteristics !!44 adults enrolled at 4 clinical sites in the US

!! 16 male, 28 female ! Mean age 37.3 (range: 18-65) years !!Cause of Scar:

!! Burn (6.8%)

!! Surgery (52.3%) !! Injury (34.1%)

!! Other (6.8%)

!!Age of Scar: !! 3-6 months (36.4%)

!! 6-9 months (31.8%)

!! 9-12 months (31.8%) !!Baseline characteristics were similar between treatment groups.

Improvement in Appearance and Symptoms

This randomized, double-blind study compared the efficacy, safety and tolerability of a Microcyn® Technology scar gel with that of a comparator, 100% silicone gel, for the management of hypertrophic or keloid scars.

A Double-blind, Randomized Study of a Microcyn® Technology Scar Gel In Comparison with 100% Silicone Gel for Hypertrophic or Keloid Scars

Alicia D. Bucko, DO, CPI, JD Academic Dermatology Associates, Albuquerque, NM; Zoe Draelos, MD, Dermatology Consulting Services, High Point, NC; Janet C. Dubois, MD, DermResearch, Inc. Austin, TX; Terry M. Jones, MD, J&S Studies, Inc. College Station, TX

!! This randomized, double blind study demonstrated greater improvements in VSS scores for vascularity, pliability and height of scars with Microcyn scar gel compared with 100% silicone gel at Day 56, Day 84, and Day 112.

!! The Investigator assessment of efficacy was good or very good in 55% of subjects on Microcyn scar gel compared with 28% of subjects on comparator at the end-of-study visit.

!! Overall Microcyn scar gel performed better than the comparator gel for the management of hypertrophic or keloid scars. Both treatments were well tolerated.

Poster presented at the 14th Annual Caribbean Dermatology Symposium, January 20-24, 2015, in St. Maarten

!! The authors gratefully acknowledge Joanna Peterkin, MD; Catherine Schmidt; Brian Martin, Antoinette Douglas, Kristina Thompson; Agility Clinical; Sure Clinical eTMF; and our study coordinators for their important contributions and dedicated work throughout this study.

Introduction

Summary

Methods

Photographic Results: Microcyn Scar Gel Results

Acknowledgements

Purpose

Vancouver Scar Scale (VSS) !! The vascularity, pliability, and height of target scars, improved

consistently over the course of the study. !! At Day 56, the mean total VSS had decreased with Microcyn scar

gel by 2.10 vs. 1.28 with the comparator. !! This improvement continued to the end-of-study visit (week 16)

reaching decreases with Microcyn scar gel of -2.70 vs. -1.83 in the comparator group.

!! The reductions in mean total VSS were greater in the Microcyn scar gel group than those in the comparator group.

Subject-rated pain and itch assessment !! Pain and itch decreased (improved) in both groups with greater

improvement with Microcyn scar gel

Investigator global assessment (IGA) !! The IGA of efficacy was good/very good in 6 (30%) subjects at Day

56 and 11 (55%) subjects at Day 112 with Microcyn scar gel.

!! This compares favorably with 5 (28%) subjects at both time points with the comparator.

Subject Global Satisfaction !! Subject Global Satisfaction was similar between treatment groups

and at various time points.

Safety !! Adverse events (AE) were reported in 4 (18%) of subjects on

Microcyn scar gel and 7 (35%) on the comparator.

!! The Investigator rated the majority of AEs as mild to moderate. !!None of the AEs in the Microcyn scar gel group were related to

treatment. One AE in the comparator group was related to treatment (application site warmth).

!!Most AEs were categorized as infections & infestations and gastrointestinal disorders not associated with treatment.

!!No TEAE occurred in more than one subject in a treatment group.

!!One SAE (rectal perforation) occurred in the Microcyn group that was not related to treatment.

!! Both treatments were well tolerated.

Funding provided by

03-004 White female with linear hypertrophic scar ((6-9 months old) on her left hand due to a burn (Baseline and 16 weeks)

01-007 White female with a keloid (6-9 months old) on her left arm due to surgery (Baseline and 16 weeks)

04-011 White female with linear hypertrophic scar (3-6 months old) due to surgery on left lower leg (Baseline and 16 weeks)

03-011 White female with a linear hypertrophic scar (3-6 months old) on her left arm due to injury (Baseline and 16 weeks)

Percent Improvement Over Baseline

at Week 12

!! Scar type: !! Linear hypertrophic (43.2%)

!! Widespread hypertrophic (9.1%) !! Keloid (50%)

White female with linear hypertropic scar (6-9 months old) on her left hand due to a burn

Baseline 16 WeeksWhite female with a linear hypertropic scar (3-6 months old) on her

left arm due to injury

Baseline 16 Weeks

The trial's primary endpoint was to compare Microcyn®-based hydrogel versuscompetitor using the Vancouver Scar Scale measuring:

3x

The study shows that usage of Dermacyn® ScarLess™ Hydrogel during early post-operative period among patients following gynaecological surgery helps to signi�cantly reduce and prevent scar formation without increasing pain and itchiness scores. Improvements were evidence in scar vascularity (p=0.025), pliability (p=0.022), height (p=0.001) and pigmentation (p=0.000).

49

Graph 1: Vancouver Scar Scale (VSS) components over study period.

Vascularity (p=0.025)

Pliability (p= 0.022)

Height (p= 0.001)

Pigmentation (p= 0.000)

49

Graph 1: Vancouver Scar Scale (VSS) components over study period.

Vascularity (p=0.025)

Pliability (p= 0.022)

Height (p= 0.001)

Pigmentation (p= 0.000)

Vascularity (p=0.025) Pliability (p= 0.022) Height (p= 0.001) Pigmentation (p= 0.000)

The study shows that usage of Dermacyn® ScarLess™ Hydrogel during early post-operative period among patients following gynaecological surgery helps to signi�cantly reduce and prevent scar formation without increasing pain and itchiness scores.

Changes of scar among patient without ScarLess™ Changes of scar among patient with ScarLess™

Day 14 without ScarLess™

Day 90 without ScarLess™

Day 14 with ScarLess™

Day 90 with ScarLess™

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Contact usTo find out more about Dermacyn® ScarLess™ Hydrogel or to discuss your requirements, please contact us and we will be happy to help.

Evaluation of Dermacyn® ScarLess™ Hydrogel in reducing scar formation post laparotomy gynaecology surgery3

(Fathi Ramly et al., 2018)

References

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Singapore O�ceDYAMED BIOTECH PTE LTD

10 Ubi Crescent,#02-41, Ubi Techpark,

Lobby C, Singapore 408564

Tel: +65 6848 1028Fax: +65 6848 2027

Malaysia O�ceDYAMED BIOTECH SDN BHD

A4-11, Block A, Plaza Dwitasik,Bandar Sri Permaisuri,

O� Jalan Permaisuri (1), 56000 Cheras,Kuala Lumpur, Malaysia

Tel: +603 9173 0128Fax: +603 9173 5128

Leading distributor of medical & diagnostic devices in Singapore & Malaysia

+6012-345 4201info@dyamed.com

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