REF/2013/02/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Mon, 23 Apr :26:25 GMT) CTRI Number Last Modified On 16/03/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/03/ [Registered on: 04/03/2013] - Trial Registered Retrospectively No al Other (Specify) [Hair Care] Other rritation potential of the given hair colour samples- Patch test Single application closed patch test to evaluate the safety of hair colour formulations on healthy human subjects. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) SRC/CD/398, Version 01, Dated :January 21,2013 Protocol Number Details of Principal Investigator V.G.Vaze College Mumbai (Suburban) Details Contact Person (Scientific Query) V.G.Vaze College Details Contact Person (Public Query) Details Contact Person (Public Query) V.G.Vaze College page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied / Comparator Agent Source of Monetary or Material Support > MARICO LTD, Marks, Plot no: 23 C,Mahal Industrial Estate, Near Ahura Centre,Mahakali Caves Road,Andheri( East) Type of Sponsor NIL List of Countries of Principal Investigator Ms Meghana Surve Primary Sponsor Details MARICO LTD Marks, Plot no: 23 C, Mahal Industrial Estate, Near Ahura Centre,Mahakali Caves Road,Andheri( East), Mumbai , Other [HAIR CARE] NIL of Site Site Phone/Fax/ The KET s, Scientific Research Centre, Cosmetology Division, The Kelkar Education Trust s, Scientific Research Centre,Cosmetology Division, 4th floor, V. G. Vaze college campus, Mithagar Road, Mulund (E), Mumbai , Mumbai (Suburban) Mumbai (Suburban) Mumbai (Suburban) meghana@kelkarcosm etology.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Independent Scientific & Ethics Committee Status Health Type Healthy Human Volunteers Approved 24/01/2013 No Date No Date Specified Condition skin patch test Type Details 1.Haircode Herbal Hair Dye- Natural Black i.e. 24 hrs. of patch application),day 3 (24 hrs. of patch removal),day 4 (48 hrs. of page 2 / 5

3 Inclusion Criteria 2.Haircode Active Herbal Powder Hair color- Natural Black 3.Haircode Active Herbal Powder Hair color- Natural Brown 4.Haircode Active Herbal Powder Hair color- Mehendi Red patch removal) and Day 9 (1 week removal), Day 4 (48 hrs. of patch removal)and Day 9 (1 week 5.EGY EGY EGY EGY-004 Comparator Agent 7.(Experimental Comparator):Sodium Lauryl Sulphate 3% Solution page 3 / 5

4 Exclusion Criteria Age From Age To Gender Year(s) Year(s) Both Inclusion Criteria Details Is a female/ male in generally good health,is between the ages of 18 and 50 years,has not participated in a similar clinical investigation in the past four weeks,is willing to give a written informed consent and come for regular observation. Details Exclusion Criteria A known history or present condition of allergic response to any cosmetic products,skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings,medications (e.g. steroids or antihistamines), which would compromise the study,pregnant or lactating Method of Generating Random Sequence Method of Concealment Blinding/Masking Case Record Numbers Open Label Primary Outcome Outcome Timepoints Irritation Potential 0hrs, 24 hrs, 48 hrs and 1 week after patch removal. Secondary Outcome Outcome Timepoints Investigational products to be tested for irritancy test On each subject s back one patch of each investigational product will be applied on Day 1. This will be 9 days study. For all the products and positive control the subjects will be assessed by the study dermatologist on Day 1 (Day of patch application), Day 2 (0 hrs. of patch removal Day 3 (24 hrs. of patch removal),day 4 (48 hrs. of patch after patch removal). Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=24 Sample Size from =24 28/01/2013 No Date Specified Years=0 Months=0 Days=9 Completed Skin Irritation Test: Irritants are substances that damage the skin. The damage will depend upon the nature, concentration and duration of exposure. Irritation is page 4 / 5

5 Powered by TCPDF ( REF/2013/02/ manifested as inflammatory responses such as erythema (redness), Oedema (swelling), and vesiculation and finally to an intense suppurate reaction without the involvement of the immune system. The irritation potential of a substance can be assessed by human patch test. page 5 / 5

REF/2014/07/ CTRI Website URL -

REF/2014/07/ CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Mon, 01 Jan 2018 18:09:26 GMT) CTRI Number Last Modified On 18/06/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study