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Claim Substantiation for
Cosmeceuticals through Clinical Testing


  AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH
Vedic. Introduction
2


       A decade of experience as full and functional service CRO
       Widest range of services for the Nutraceuticals, Dietary Supplements,
        Botanical Drug Products, Medical Foods, Natural Health Products,
        Cosmetics & Personal Care Products
       Clinical trials for label claim substantiation
       Compliant data to meet regulatory requirements
       Efficient study design for testing cosmetic products
       Cosmetic efficacy studies
       Quality check of developed product
       Delivery of safe and effective products to the customers.
       ISO 9001:2008 certified
       Headquarters in Mumbai, india with office in California, USA
Vedic. Services
3
Vedic. Benefits
4

       Experienced team of medical experts with experience in studies for Acne,
        Melasma, Weight Loss, Hair removals, etc
       Claim Substantiations possible - “Clinically Proven” tags at affordable
        costs
       Protocols made in accordance with ICH-GCP
       Unmatched Quality, Effective Costs and Reduced Timelines
       End to end service provider for all your products
       Quality Research for better market acceptance
Vedic. Capabilities
5


              SKIN                         HAIR                 OTHERS
       Lightening/Fairness      Cleaning                 Oral Hygiene
       Anti-ageing               /Conditioning            Eye care
       Acne/oil control
                                 Growth stimulation       Weight Loss and
       Blemishes/Marks
                                 Growth retardation        Management

       Softness/Elasticity
                                 Dandruff Control

       Body odour
                                 Styling / Colouring

       Excessive sweating
                                 Repair


                                                                       5
Vedic. Site Capabilities
6

       Access to Right Set of Volunteers
       Comprehensive and Independent Facility
       Specialized in Cosmetics, Cosmeceutical and Dermatological Safety and
        Efficacy studies
       Offer services to National and International sponsors for Safety as well as
        Efficacy Testing
       Fulfill client’s expectations with Reliable, Consistent and Efficient
        performance
Vedic. Invitro Tests
7

       Invitro screening of herbal extracts for cosmeceutical applications
       Skin irritation
       Phototoxicity
       E.g: Invitro SPF testing: Estimation of protection from UVB (short wave
        UV light) and UVA (long wavelength UV light)
       Instrument Used: Optometrics LLC, SPF- 290S
       Assist in product development stage
Vedic. Safety Studies – Standards & Methods
8

       Standards followed:
         ASTM

         BIS

       Primary Irritation Patch Test:
           To ascertain the safety in terms of irritation potential of the cosmetic
            products against a positive control on the healthy human subjects
       Repeat Insult Patch Test:
           The objective of this test is to determine the irritation and/or sensitization
            potential of the test material(s) after repeated application under occlusive,
            semi- occlusive or open patches to the skin of human subjects
               The above are based on Client requests and preferences
Vedic. Clinical Studies Expertise
9

       Clinical studies compliant to ICH –GCP
       Experienced medical writing team
       Dedicated project management team
       ICH-GCP trained and qualified clinical research monitors
       Independent ethics committee approvals
       Evaluations for clinical studies based on:
           Expert dermatologist assessment
           Instrument assessment
           Self assessment carried out by the volunteers
       Comprehensive data management and statistical analysis
       Final report writing
Vedic. Investigators
10


        Rich experience in managing Dermatology and Venereology
         patients
        Dynamic, energetic and result oriented professionals
        Ability to deliver quality data within specified timelines
Vedic. Instrumental Capabilities
11


     Instrument     Measures                               Evaluates efficacy of
     Visiometer®    Wrinkle Depth                          Anti Ageing Products
     Cutometer®     Skin Elasticity                        Anti Ageing Products


     Tewameter®     Skin Softness                          Moisturizers
     Chromameter®   Skin color according to pigmentation   Fairness creams, tanning products
     Mexameter®     Skin melanin content / erythema        Fairness creams, tanning products, anti-
                                                           marks creams
     Sebumeter®     Skin Oiliness                          Anti-acne products
     Corneometer®   Skin Moisture                          Moisturizers
     Visioscan®     Skin Surface Texture                   Moisturizers
     Skin Ph®       pH-level on the skin surface           Soaps, Face Wash
SKIN LIGHTENING
     Visiometer®
     Manufacturer: Courage + Khazaka electronic GmbH
12




        Studies the skin surface directly with Special UV-A light
        Shows the skin structure and level of dryness
        Evaluates desquamation and sebum production
Elasticity / Anti – ageing
     Cutometer ®
     Manufacturer: Courage + Khazaka electronic GmbH
13




        Measures precise skin elasticity
                                Elasticity


           1
         0.9
         0.8
         0.7
         0.6
         0.5
         0.4
         0.3
         0.2
     m
     R
     C
     g
     n
     d
     o
     u
     a
     e
     r
     t
     i




         0.1
           0
               0    10    20    30     40    50   60   70    80
                                      Age




               The chart shows elasticity as a function of age



                                                                  13
Skin Softness
     Tewameter ®
     Manufacturer: Courage + Khazaka electronic GmbH
14



          Measures trans epidermal water loss
          Evaluates efficiency of the skin water barrier

                         Moisture-Locking Ability


           6.0


           5.0

           4.0


           3.0


           2.0
       W
       m
       E
       h
       g
       L
       T
       2
       )
       (
       /




           1.0

           0.0
                 0   4    8                12          16      20   24

                                       No. of hrs



                              Lotion         Cream   Control




                                                                         14
Skin Fairness
     Chromameter ®
     Manufacturer: Konica Minolta
15



        Measures the skin color according to
             L* Lightness
              a* Redness
              b* yellowness




                                                15
Skin Fairness
     Mexameter ®
     Manufacturer: Courage + Khazaka electronic GmbH
16




        Measure the two components, mainly responsible for the
         colour of the skin:

         Melanin and Hemoglobin (erythema)




                                                             16
Skin oiliness
     Sebumeter®
     Manufacturer: Courage + Khazaka electronic GmbH
17




         Allows determination of even slightest changes in the skin
          surface sebum content

         Measures oiliness in acne prone skin




                                                                   17
Skin softness
     Corneometer ®
     Manufacturer: Courage + Khazaka electronic GmbH
18




         Measures skin moisture levels




                                                       18
Skin dryness
     Visioscan®
     Manufacturer: Courage + Khazaka electronic GmbH
19


          Measures the level of dryness of the skin
          Measures desquamation on skin and scalp
          Evaluates sebum production




                                                       19
Skin pH
     Skin-pH-Meter®
     Manufacturer: Courage + Khazaka electronic GmbH
20




         Evaluates the quality of the Hydrolipidic film on the skin
          especially in developing soaps, cleanser or detergents




                                                                       20
Vedic. Key people
21




            Jayesh Chaudhary is Founder & Managing Director of Vedic Lifesciences. He has been
            involved in product development and international business since 1994. He is thorough with
            regulatory affairs, research and marketing for nutraceutical and phyto-pharmaceutical actives
            and formulations for the EU and US markets. Trained in Pharmacy and Microbial
            Engineering from University of Minnesota, Jayesh was responsible for the Biocatalyst and
            Natural Products technical support and national sales at Boehringer Mannheim India in the
            early ‘90s.


            • Dr. Navneet Sonawane is heading the Clinical Research Department. She has 12 years
              of experience in the field of Medical Science & Clinical Research, which include areas
              such as Medical Writing, Regulatory Affairs, Project Management & QA. She has
              successfully headed Global Clinical Studies across various therapeutic segments. During
              her tenure at Vedic, she has developed a strong network of GCP trained clinical
              investigators around India and has been appreciated by Sponsors around globe. She
              places a high premium for meeting time line while ensuring delivering of quality.
Vedic. Key people
22




         Kunal Bhatt has 8 years of experience within the pharmaceutical industry, having led
         several Global Phase I - IV drug studies in various capacities and diverse therapeutic areas
         like Neurology, Psychiatry (Adult and Pediatric), Oncology, Diabetes, Urology and Cardiology.
         Masters in Pharmacology and Biotech from Sheffield Hallem University, UK, Kunal has worked
         in areas of Global Project Management, Clinical Operations and Regulatory. As a Global
         Business Development Manager his good business planning acumen and interpersonal relations
         help in crafting Business & Marketing Plans.



          ANIL YADAV leads VL’s QA department. After completing his graduation in
          Microbiology he obtained a Master degree in Biochemistry from the Mumbai University.
          He brings in over 7 years of experience in the field of Quality Assurance with actual
          hands on experience in Product development, Documentation and Training.. His focus at
          VL on System development and Training activities has helped in constant up-gradation of
          our expertise and abilities.
Vedic. Key people
23



         Sakshi Pawar is involved in handling Feasibility and Project Management of trials at
         Vedic and has over 11 years of professional experience in Clinical Research. During
         this period she has actively participated in sponsor/regulatory audits, including those
         conducted by USFDA, MHRA, EMEA and DCGI. . Sakshi has completed her
         Diploma in Clinical Research and General Nursing and Midwifery. She has worked
         for BA-BE studies.


         Seema Damakale has got a total work experience of 7 years in Pharma and
         Research industry. She has played various roles during her tenure, right from Sales
         and Marketing to Quality Assurance and now, Project Management. With her
         exuberance and dedication towards project work and her quest for meeting
         timelines, she has been an excellent role model. Seema is a Science Graduate and
         has completed her Post Graduate Diploma in Clinical Research and Diploma in
         Business Management.
24


                                India
      203, Morya Landmark 1, Off new Link Road, Andheri West,
                            Mumbai 400053
              Tel.: +91 22 42172300 / +91 22 42025719

                                   USA
     552, Shorebird Circle, Unit #1101, Redwood Shores, CA. 94065
                     Tel.: (650) 855-4832

     bizdev@vediclifesciences.com, www.vediclifesciences.com

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Claim substantiation for Cosmeceuticals / Personal Care Products through Human Clinical testing

  • 1. Claim Substantiation for Cosmeceuticals through Clinical Testing AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH
  • 2. Vedic. Introduction 2  A decade of experience as full and functional service CRO  Widest range of services for the Nutraceuticals, Dietary Supplements, Botanical Drug Products, Medical Foods, Natural Health Products, Cosmetics & Personal Care Products  Clinical trials for label claim substantiation  Compliant data to meet regulatory requirements  Efficient study design for testing cosmetic products  Cosmetic efficacy studies  Quality check of developed product  Delivery of safe and effective products to the customers.  ISO 9001:2008 certified  Headquarters in Mumbai, india with office in California, USA
  • 4. Vedic. Benefits 4  Experienced team of medical experts with experience in studies for Acne, Melasma, Weight Loss, Hair removals, etc  Claim Substantiations possible - “Clinically Proven” tags at affordable costs  Protocols made in accordance with ICH-GCP  Unmatched Quality, Effective Costs and Reduced Timelines  End to end service provider for all your products  Quality Research for better market acceptance
  • 5. Vedic. Capabilities 5 SKIN HAIR OTHERS  Lightening/Fairness  Cleaning  Oral Hygiene  Anti-ageing /Conditioning  Eye care  Acne/oil control  Growth stimulation  Weight Loss and  Blemishes/Marks  Growth retardation Management  Softness/Elasticity  Dandruff Control  Body odour  Styling / Colouring  Excessive sweating  Repair 5
  • 6. Vedic. Site Capabilities 6  Access to Right Set of Volunteers  Comprehensive and Independent Facility  Specialized in Cosmetics, Cosmeceutical and Dermatological Safety and Efficacy studies  Offer services to National and International sponsors for Safety as well as Efficacy Testing  Fulfill client’s expectations with Reliable, Consistent and Efficient performance
  • 7. Vedic. Invitro Tests 7  Invitro screening of herbal extracts for cosmeceutical applications  Skin irritation  Phototoxicity  E.g: Invitro SPF testing: Estimation of protection from UVB (short wave UV light) and UVA (long wavelength UV light)  Instrument Used: Optometrics LLC, SPF- 290S  Assist in product development stage
  • 8. Vedic. Safety Studies – Standards & Methods 8  Standards followed:  ASTM  BIS  Primary Irritation Patch Test:  To ascertain the safety in terms of irritation potential of the cosmetic products against a positive control on the healthy human subjects  Repeat Insult Patch Test:  The objective of this test is to determine the irritation and/or sensitization potential of the test material(s) after repeated application under occlusive, semi- occlusive or open patches to the skin of human subjects The above are based on Client requests and preferences
  • 9. Vedic. Clinical Studies Expertise 9  Clinical studies compliant to ICH –GCP  Experienced medical writing team  Dedicated project management team  ICH-GCP trained and qualified clinical research monitors  Independent ethics committee approvals  Evaluations for clinical studies based on:  Expert dermatologist assessment  Instrument assessment  Self assessment carried out by the volunteers  Comprehensive data management and statistical analysis  Final report writing
  • 10. Vedic. Investigators 10  Rich experience in managing Dermatology and Venereology patients  Dynamic, energetic and result oriented professionals  Ability to deliver quality data within specified timelines
  • 11. Vedic. Instrumental Capabilities 11 Instrument Measures Evaluates efficacy of Visiometer® Wrinkle Depth Anti Ageing Products Cutometer® Skin Elasticity Anti Ageing Products Tewameter® Skin Softness Moisturizers Chromameter® Skin color according to pigmentation Fairness creams, tanning products Mexameter® Skin melanin content / erythema Fairness creams, tanning products, anti- marks creams Sebumeter® Skin Oiliness Anti-acne products Corneometer® Skin Moisture Moisturizers Visioscan® Skin Surface Texture Moisturizers Skin Ph® pH-level on the skin surface Soaps, Face Wash
  • 12. SKIN LIGHTENING Visiometer® Manufacturer: Courage + Khazaka electronic GmbH 12  Studies the skin surface directly with Special UV-A light  Shows the skin structure and level of dryness  Evaluates desquamation and sebum production
  • 13. Elasticity / Anti – ageing Cutometer ® Manufacturer: Courage + Khazaka electronic GmbH 13  Measures precise skin elasticity Elasticity 1 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 m R C g n d o u a e r t i 0.1 0 0 10 20 30 40 50 60 70 80 Age The chart shows elasticity as a function of age 13
  • 14. Skin Softness Tewameter ® Manufacturer: Courage + Khazaka electronic GmbH 14  Measures trans epidermal water loss  Evaluates efficiency of the skin water barrier Moisture-Locking Ability 6.0 5.0 4.0 3.0 2.0 W m E h g L T 2 ) ( / 1.0 0.0 0 4 8 12 16 20 24 No. of hrs Lotion Cream Control 14
  • 15. Skin Fairness Chromameter ® Manufacturer: Konica Minolta 15  Measures the skin color according to L* Lightness a* Redness b* yellowness 15
  • 16. Skin Fairness Mexameter ® Manufacturer: Courage + Khazaka electronic GmbH 16  Measure the two components, mainly responsible for the colour of the skin: Melanin and Hemoglobin (erythema) 16
  • 17. Skin oiliness Sebumeter® Manufacturer: Courage + Khazaka electronic GmbH 17  Allows determination of even slightest changes in the skin surface sebum content  Measures oiliness in acne prone skin 17
  • 18. Skin softness Corneometer ® Manufacturer: Courage + Khazaka electronic GmbH 18  Measures skin moisture levels 18
  • 19. Skin dryness Visioscan® Manufacturer: Courage + Khazaka electronic GmbH 19  Measures the level of dryness of the skin  Measures desquamation on skin and scalp  Evaluates sebum production 19
  • 20. Skin pH Skin-pH-Meter® Manufacturer: Courage + Khazaka electronic GmbH 20  Evaluates the quality of the Hydrolipidic film on the skin especially in developing soaps, cleanser or detergents 20
  • 21. Vedic. Key people 21  Jayesh Chaudhary is Founder & Managing Director of Vedic Lifesciences. He has been involved in product development and international business since 1994. He is thorough with regulatory affairs, research and marketing for nutraceutical and phyto-pharmaceutical actives and formulations for the EU and US markets. Trained in Pharmacy and Microbial Engineering from University of Minnesota, Jayesh was responsible for the Biocatalyst and Natural Products technical support and national sales at Boehringer Mannheim India in the early ‘90s. • Dr. Navneet Sonawane is heading the Clinical Research Department. She has 12 years of experience in the field of Medical Science & Clinical Research, which include areas such as Medical Writing, Regulatory Affairs, Project Management & QA. She has successfully headed Global Clinical Studies across various therapeutic segments. During her tenure at Vedic, she has developed a strong network of GCP trained clinical investigators around India and has been appreciated by Sponsors around globe. She places a high premium for meeting time line while ensuring delivering of quality.
  • 22. Vedic. Key people 22 Kunal Bhatt has 8 years of experience within the pharmaceutical industry, having led several Global Phase I - IV drug studies in various capacities and diverse therapeutic areas like Neurology, Psychiatry (Adult and Pediatric), Oncology, Diabetes, Urology and Cardiology. Masters in Pharmacology and Biotech from Sheffield Hallem University, UK, Kunal has worked in areas of Global Project Management, Clinical Operations and Regulatory. As a Global Business Development Manager his good business planning acumen and interpersonal relations help in crafting Business & Marketing Plans. ANIL YADAV leads VL’s QA department. After completing his graduation in Microbiology he obtained a Master degree in Biochemistry from the Mumbai University. He brings in over 7 years of experience in the field of Quality Assurance with actual hands on experience in Product development, Documentation and Training.. His focus at VL on System development and Training activities has helped in constant up-gradation of our expertise and abilities.
  • 23. Vedic. Key people 23 Sakshi Pawar is involved in handling Feasibility and Project Management of trials at Vedic and has over 11 years of professional experience in Clinical Research. During this period she has actively participated in sponsor/regulatory audits, including those conducted by USFDA, MHRA, EMEA and DCGI. . Sakshi has completed her Diploma in Clinical Research and General Nursing and Midwifery. She has worked for BA-BE studies. Seema Damakale has got a total work experience of 7 years in Pharma and Research industry. She has played various roles during her tenure, right from Sales and Marketing to Quality Assurance and now, Project Management. With her exuberance and dedication towards project work and her quest for meeting timelines, she has been an excellent role model. Seema is a Science Graduate and has completed her Post Graduate Diploma in Clinical Research and Diploma in Business Management.
  • 24. 24 India 203, Morya Landmark 1, Off new Link Road, Andheri West, Mumbai 400053 Tel.: +91 22 42172300 / +91 22 42025719 USA 552, Shorebird Circle, Unit #1101, Redwood Shores, CA. 94065 Tel.: (650) 855-4832 bizdev@vediclifesciences.com, www.vediclifesciences.com

Editor's Notes

  1. Chromameter readings are expressed as a 3-digit output L*a*b* where L* measures skin reflectance or lightness—this is a gray scale with values from 0 to 100 where 0 is black and 100 is white; a* measures the color saturation from red to green—the scale is from + 60 to -60, where positive values indicate varying intensities of red; b* measures the color saturation from yellow to blue—the scale is also from + 60 to -60, where positive values indicate varying intensities of yellow