v.0916877.777.2305 | osmosisskincare.com

Independent, Monadic IRB-Reviewed Study of 56 people, 60% saw a reduction in skin imperfections and blemishes.

of test subjects had an improvement in complexion health, texture and smoothness of their skin.100%

CLINICAL STUDY

Four-Week Clinical Study Evaluates the Effects of

Harmonized Water on Facial Blemishes

100.00%

50.00%

0.00%PIH

Improvement

15.78%

OverallAppearance

25.63%

Active Lesions

29.70%

ComplexionHealth

30.87%

Texture / Smoothness

(Visual)

31.38%

Open and Closed

Comedones

49.20%

MEAN ACNE IMPROVEMENT IN 4 WEEKS

SKIN PERFECTION HARMONIZED WATER USE AFTER 4 WEEKS

Papules

80.00%

0%

10%

20%

30%

40%

50%

60%

70%62.9%54.3%

51.4%51.4%48.6%

60%

Saw a reduction of skin imperfections and blemishes

Felt the product prevented blemishes

Saw improved appearance in skin

Saw improvement in blemishes and skin complexion

Felt their skin tone was more even and clear

Felt their skin was smoother

7 .3.1 Procedure Summary Table

Procedures Washout Baseline Week4

Informed Consent and Medical X

Study Initiation and History Qualification Inclusion/Exclusion Criteria

X X reviewed

Compliance check, updated medical history, AE reportin!? X X

Dispense/ Collect Products D D

Suvvort Test

- Texture (visual)Expert Clinical - Global Acne Severity

X X Grading - Lesion count

- Overall Appearance

Photography Clarity 2D Research Ti (L, R, C

X X views)subwoup of 10

Image Analysis Acne Lesions X X

Consumer Perception Subjective Questionnaire X

8.0 Concomitant Medications and Products

The use of any topical cleansers and skin treatment products (other than those assigned during the study) on the

face was prohibited during the washout and study periods. This included, but was not limited to moisturizers,

serums, cleansers and medicated creams. Use of color-cosmetics which subjects were regularly using at time of

study enrollment was allowed during study period. No new cosmetics or personal care products were to be

introduced for the duration of the study. Use of certain other systemic and topical medications and treatments

products was prohibited during the study per Section 5.3.

9.0 Adverse Events

No adverse events were reported during the conduct of this study.

10.0 Institutional Review Board

IRB review was performed and approved.

11.0 Informed Consent

The informed consent process was completed prior to an individual's involvement in any study related activity.

The process was documented using a written informed consent form (ICF) conforming to FDA 21 CFR 50.25 (See

Appendix I Protocol, Section 11.0 and Appendix IV).

After review, two copies of the ICF were signed and dated by the individual and the Principal Investigator or his

designee administering the consent. One original copy was retained by IRSI and the other was given to the

individual.

12.0 Discontinuation of Study

The study was completed on schedule as per the clinical study protocol (and subsequent amendments).

Table 3.0 Expert Clinical Grader Evaluation - Monadic, comparison to Baseline

Placebo Waves Skin Harmony Harmonized Water

Mean Percent of Mean Percent of

Time Percent Subjects Percent Subjects P-ValueAssessment

Point n Improveme Showing P-Value n Mean± lmproveme Showing

Mean± SD TXvs. nt Improvemen TX vs. Bl SD nt Improvem

Bl From Bl t From Bl ent mean From Bl mean From Bl

Baseline 21 4.75 ±I.II 35 4.53 ±

Texture/ 0.43 Smoothness

27.05% 100% (Tactile) Week4 21 3.84 ± 1.17 16.31% 82.9%

<0.001* 35 3.31 ±

<0.001 * 0.74

Baseline 21 4.84 ± 1.10 35 4.77±

Texture/ 0.47 Smoothness

100% (Visual) Week4 21 3.73±1.15 19.69% 80.0%

<0.001* 35 3.28 ± 31.38%

<0.001 * 0.65

Baseline 21 4.80 ± 1.16 35 4.92 ±

Overall 0.56

Appearance Week4 21 4.04± 1.20

14.36% 71.4% <0.001* 35

3.69 ± 25.63% 95.2% <0.001•

0.88

Baseline 21 5.14 ± 0.98 35 5.20 ±

Complexion 0.78

Health 19.53% 82.9% 3.62 ± 30.87% 100% <0.001 * Week4 21 4.09 ± 1.32 <0.001 * 35

0.94

*Indicates a statistically significant improvement compared to baseline, p:50.05

Table 3.1 Expert Clinical Grader Evaluation - Product Comparison

Placebo Waves Skin Harmony

Assessment Time Harmonized Water P, Value

Point n

Mean Difference :I: SD n

Mean Difference :I: SD AvsB

From Bl From Bl

Texture/ Smoothness (Tactile) Week4 21 -0.91 ± 1.18 35 -1.21±0.61 0.020A

Texture/ Smoothness (Visual) Week4 21 -1.11 ± 1.24 35 -1.49 ± 0.52 0.01.8A

Overall Appearance Week4 21 -0.76 ± 0.90 35 -1.23 ± 0.60 0.022A

Complexion Health Week4 21 -1.04 ± 1.23 35 -1.58 ± 0.59 0.035" . .

Product Waves Skin Harmony Harmonized Water s1gn1f1cantly outperformed Product Placebo

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5

Table 5.0 Consumer Perception - Subjective Questionnaire - Week 4

Waves Skin Harmony Harmonized Water

Strongly Question n Agree

Agree

1. The test product made my skin 35

1 17 tone look more clear and even. (2.9%) (48.6%) 2. The test product decreased theappearance of discolorations caused

35 1 11

by imperfections and blemished on (2.9%) (31.4%) my facial skin. 3. The test product made my facial

35 9 13

skin feel smoother. (25.7%) (37.1%) 4. The test product made my facial

35 10 14

skin feel softer. (28.6%) (40.0%) 5. My facial skin appears less dull

2 13 and more radiant after using the test 35

(5.7%) (37.1) product.6. The test product helped improvemy facial skin imperfections and

35 2 15

blemished and gave homogenous (5.7%) (42.9%) complexion of my facial skin. 7. The test product improved the imperfection and blemished on my

1 10 facial skin, illuminating my 35

(2.9%) (28.6%) complexion with a fresh youthinfused glow.8. The test product game my skin a

35 0 9

flawless look. (0.0%) (25.7%) 9. The test product reduced the

35 3 13

number of lesions on my facial skin. (8.6%) (37.1%) 10. The test product reduced the

1 20 number of skin imperfections and 35

(2.9%) (57.1%) blemished on my facial skin. 11. It appears that the test productprevented the formation of new

35 4 13

lesions on my facial skin whiles using (11.4%) (37.1%) test product for four weeks. 12. It appears that the test product prevented the appearance of new

4 14 imperfections and blemishes on my 35 (11.4%) (40.0%)

skin while using the test product forfour weeks.13. The product improved the

35 2 13

quality of my facial skin. (5.7%) (37.1%) 14. The product improved the

35 5 14

overall appearance of my facial skin. (14.3%) (40.0%) 15. The test product did not irritate

13 16 my facial skin during the four week 35

(37.1%) (45.7%) treatment period.Bold/ Shaded = The majority of subjects responded favorably, >50%. A Waves Skin Harmony Harmonized Water Outperformed Placebo 6 Placebo Outperformed Waves Skin Harmony Harmonized Water

Strongly Neutral Disagree

Disagree

Response n (%) 9

7 (20.0%) 1

(25.7%) (2.9%)

11 11 1 (31.4%) (31.4%) (2.9%)

9 3 1 (25.7%) (8.6%) (2.9%)

6 4 (11.4%)

1 (17.1%) (2.9%)

13 1 (37.1%)

6 (17.1%) (2.9%)

9 7 (20.0%)

2 (25.7%) (5.7%)

13 2 (37.1%)

9 (25.7%) (5.7%)

12 10 4 (34.3%) {28.6%) (11.4%)

5 12 2 (14.3%) (34.3%) (5.7%)

1 11 2 (2.9%) (31.4%) (5.7%)

7 8 (22.9%)

3 (20.0%) (8.6%)

5 10 2 (14.3%) (28.6%) (5.7%)

13 6 (17.1%)

1 (37.1%) (2.9%)

6 9 (25.7%)

1 (17.1%) (2.9%)

3 0 3 (8.6%)

(8.6%) (0.0%)

Wilcoxon Percent

Responding Z-Score PrValue

Favorably

A vsB

51.4% -5.9522 <0.001A

34.3% -6.0308 <0.QQlA

62.9% -5.1520 <O.OOlA

68.6% -5.2820 <0.001A

42.9% -5.9683 <0.001A

48.6% -5.9833 <0.001A

31.4% -6.1540 <0.001A

25.7% -6.2064 <O.OOlA

45.7% -5.9232 <0.001A

60.0% -5.8924 <0.001A

48.6% -5.6088 <0.001A

51.4% -5.6542 <O.OOlA

42.9% -5.9833 <0.QQlA

54.3% -5.7115 <0.001A

82.9% -3.6842 <0.001A

IRSI, Inc. Protocol No. 39520SM0715.0 and .1

Draft Report Ver. 2.0

April 28, 2016

19.2 Discussion

19.2.1 Enrollment and Demographics

At least 55 male and female subjects, ages 13 to 40 years old, were required to complete

study participation. The study completed with 56 male and female subjects with an age

range of 14 to 38 years old and an average age of 23.07 years old. The study population's

reported ethnicity was 57.1% Non-Hispanic or Latino and 42.9% Hispanic or Latino, while its

reported racial diversity was 42.9% White, 21.4% African American or Black, 7.1% each of

Multi-racial and "Other" and 21.4% No Response (Hispanic). Fitzpatrick Skin Types I-VI was

represented along with Combination, Dry, Normal and Oily Skin.

19.2.2 Expert Visual Grading

Analysis of results revealed statistically significant, improvement from Baseline in mean

scores for the appearance of facial skin's texture/smoothness (tactile and visual), overall

appearance, and complexion health after four weeks of test product use. Comparative data

with placebo group revealed statistically significant improvement compared to placebo for

the appearance of facial skin's texture/smoothness (tactile and visual), overall appearance,

and complexion health after four weeks of test product use

19.2.3 Lesion Counts

A statistically significant decrease (improvement) from Baseline was seen in the mean

number of closed comedones total non-inflammatory lesions and total lesion count after

four weeks of use. Comparative data with placebo group revealed statistically significant

improvement compared to placebo in the mean number of closed comedones, total non­

inflammatory lesions. pustules and total lesion count after four weeks of use.

19.2.4 Subjective Questionnaire

After four weeks of use, the majority of subjects (>50%) responded favorably ("agree" or

"strongly agree") to the statements "The test product made my skin tone look more clear

and even", "The test product made my facial skin feel smoother", "The test product made

my facial skin feel softer", "The test product gave my skin a flawless look", "The test

product reduced the number of skin imperfections and blemishes on my facial skin", "It

appears that the test product prevented the formation of new lesions on my facial skin

while using [it] for four weeks", "It appears that the test product prevented the

appearance of new imperfections and blemishes on my skin while using [it] for four

weeks", "The product improved the quality of my facial skin", "The product improved the

overall appearance of my facial skin" and "The test product did not irritate my facial skin

during the four week treatment period". Additionally, the majority of questions were

responded significantly more favorable in those randomized to the active product compared

to those receiving placebo.

20.0 Conclusion

In conclusion, under the conditions of this study, use of Waves "Skin Harmony" Harmonized Water

#852543005277 led to significant reduction in lesions, as evidenced by results from lesion counts, and

subjective questionnaire results. Further, subjective questionnaire results showed that the majority of

CONFIDENTIAL Appendix I L

IRSI, Inc. Protocol No. 39520SM0715.0 and .1

Draft Report Ver. 2.0

April 28, 2016

subjects believed that test product use resulted in improvements in the appearance of facial skin,

prevention of formation of new blemishes and acne lesions, and that the test product did not irritate

facial skin. Furthermore these results were statistically significant compared to placebo.

CONFIDENTIAL Appendix! L

Before #1 Before #2 Before #3

After #1 After #2 After #3