Claims Substantiation for Cosmetic Agents
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Clinical and Non- Clinical and Non- Clinical Studies For Clinical Studies For Cosmetics Cosmetics Vedic Lifesciences Vedic Lifesciences Pvt Ltd Pvt Ltd
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Transcript of Claims Substantiation for Cosmetic Agents
Clinical and Non-Clinical Clinical and Non-Clinical Studies For CosmeticsStudies For Cosmetics
Vedic Lifesciences Pvt LtdVedic Lifesciences Pvt Ltd
Hair Products Tested Fairness Studies
Sun Blocks –SPF Tested
Anti Ageing Studies
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Cosmeceuticals – The need of the hour
The Food, Drugs and Cosmetics Act defines cosmetics as The Food, Drugs and Cosmetics Act defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into or otherwise applied to the human body for introduced into or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the cleansing, beautifying, promoting attractiveness, or altering the appearance.”appearance.”
Claim Substantiations for each of them is now possible- “Clinically Claim Substantiations for each of them is now possible- “Clinically Proven” tags at affordable costs.Proven” tags at affordable costs.
Quality Research for better exports.Quality Research for better exports.
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Importance of the Skin
Skin: 16% of our total body weightSkin: 16% of our total body weight
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Parameters Tested @ Vedic – Skin Care
SKIN:
LighteningLightening
AgeingAgeing
Acne / oil controlAcne / oil control
Redness/Sensitive skinRedness/Sensitive skin
Blemishes/MarksBlemishes/Marks
MoisturizersMoisturizers
Deodorant/PerfumesDeodorant/Perfumes
PowdersPowders
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Parameters Tested @ Vedic – Hair Care
HAIR:HAIR:
Cleaning /ConditioningCleaning /Conditioning
Growth stimulationGrowth stimulation
Growth retardationGrowth retardation
Dandruff ControlDandruff Control
Styling / ColouringStyling / Colouring
RepairRepair
OTHERS:OTHERS:
Mouthwash, ToothpastesMouthwash, Toothpastes
Weight Loss and ManagementWeight Loss and Management
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Invitro Tests
Tests: Invitro ( laboratory, cell) and Invivo Tests: Invitro ( laboratory, cell) and Invivo (human volunteers)(human volunteers)
Invitro: Helpful in product developmen stage. Invitro: Helpful in product developmen stage. Eg: SPF: Estimation of protection from UVB Eg: SPF: Estimation of protection from UVB (short wave UV light) and UVA (long (short wave UV light) and UVA (long wavelength UV light).wavelength UV light).
Instrument Used: Optometrics LLC, SPF- Instrument Used: Optometrics LLC, SPF- 290S.290S.
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Safety Studies – Standards Used
Testing the Safety: standard methods used are Testing the Safety: standard methods used are as per BIS and ASTM.as per BIS and ASTM.
PIPT studies: These are patch tests conducted on PIPT studies: These are patch tests conducted on volunteers as per BIS, to study any irritation volunteers as per BIS, to study any irritation potential of the active/ product.potential of the active/ product.
RIPT Studies. These are studies conducted on a RIPT Studies. These are studies conducted on a larger group of volunteers as per ASTM larger group of volunteers as per ASTM standards to study any sensitization due to the standards to study any sensitization due to the active/ product.active/ product.
The above are based on Client requests and The above are based on Client requests and preferencespreferences
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Product Efficacy Studies
Clinical Data on VolunteersClinical Data on Volunteers
Measurements done by different routesMeasurements done by different routes
Expert EvaluationExpert Evaluation
Instrument EvaluationInstrument Evaluation
Self Assessment carried out by the Self Assessment carried out by the volunteersvolunteers
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Services Offered
–In-House Medical WritingIn-House Medical Writing
–ICH-GCP Trained and Qualified Clinical ICH-GCP Trained and Qualified Clinical Research Monitors and Clinical Research Co-Research Monitors and Clinical Research Co-ordinatorsordinators
–Independent Ethics ClearanceIndependent Ethics Clearance
–In-House Data Management In-House Data Management
–Statistical Analysis and Final Report WritingStatistical Analysis and Final Report Writing
Why Choose Vedic?
–Vedic has an in-house team of medical experts Vedic has an in-house team of medical experts who have an experience in a variety of trials who have an experience in a variety of trials conducted for Acne, Melasma, Weight Loss, Hair conducted for Acne, Melasma, Weight Loss, Hair removals, etc.removals, etc.
–The protocols made are in accordance with ICH-The protocols made are in accordance with ICH-GCP. GCP.
–Unmatched Quality, Effective Costs and Unmatched Quality, Effective Costs and Reduced Timelines form the core of our services.Reduced Timelines form the core of our services.
–End to end service provider for all your productsEnd to end service provider for all your products
Instruments Used for accurate readings
INSTRUMENTS – SKIN CARE
VISIOSCAN®VC98. VISIOSCAN®VC98.
Studies the skin surface directlyStudies the skin surface directly
UVA light video Camera.UVA light video Camera.
Shows the skin structure and level of Shows the skin structure and level of drynessdryness
Baseline After 4 Baseline After 4 weeksweeks
INSTRUMENTS –SKIN CARE
Cutometer ® – Cutometer ® – Visioelasticity by Visioelasticity by Suction.Suction.
Elasticity Elasticity measurements with measurements with this instrument are this instrument are precise and considered precise and considered as standard.as standard.
The chart shows The chart shows elasticity as a function elasticity as a function of ageof age
Elasticity
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0 10 20 30 40 50 60 70 80
Age
Cu
tom
eter
Rea
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g
INSTRUMENTS – SKIN CARE
Tewameter ®Tewameter ®
Measures trans Measures trans epidermal water epidermal water lossloss
Evaluates Evaluates efficiency of the efficiency of the skin water barrier.skin water barrier.
Moisture-Locking Ability
0.0
1.0
2.0
3.0
4.0
5.0
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0 4 8 12 16 20 24
No. of hrsT
EW
L (
g/m
2/h
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Lotion Cream Control
Overall skin colour Improvement
Method: Method: Instrumental Instrumental Measurement Measurement
Chromameter – L* Chromameter – L* Lightness, a* Lightness, a* Redness and b* Redness and b* yellowness valuesyellowness values
Chromameter CR-Chromameter CR-400400
Skin Tone Evenness -Improvement
Method: Pixel Luminosity determination – Method: Pixel Luminosity determination – High Resolution digital imagesHigh Resolution digital images
Skin Tone Evenness -Improvement
Method: Pixel luminosity variance Method: Pixel luminosity variance determination of high resolution digital determination of high resolution digital imagesimagesBaseline 2 monthsBaseline 2 months
Mexameter – Skin Colour
Human eye – capable of comparing colours Human eye – capable of comparing colours viewed side by side.viewed side by side.
The instrument- The colours viewed The instrument- The colours viewed separately, the comparisons are quick, easy separately, the comparisons are quick, easy and reliable.and reliable.
Measures components responsible for skin Measures components responsible for skin colour – Melanin and haemoglobin colour – Melanin and haemoglobin (erythema)(erythema)
Contact us at:
VEDIC LIFESCIENCES PVT. LTD
Mansi Ahuja
Business Development Executive
Contact: 02242172300/ Dir:10
www.vediclifesciences.com
Thank YouThank You
