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1 Clinical Trial Details (PDF Generation Date :- Tue, 02 Oct :40:33 GMT) CTRI Number Last Modified On 26/12/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/02/ [Registered on: 28/02/2012] - Trial Registered Prospectively No Interventional Ayurveda Randomized, Parallel Group, Placebo Controlled Trial Study to evaluate the effectiveness and tolerance of herbal anti wrinkle cream in facial wrinkles of Healthy Human Subjects A Phase II, double blind placebo controlled, monocentric study to evaluate the efficacy and tolerance of herbal anti wrinkle cream in facial wrinkles of 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) Designation Affiliation Details of Principal Investigator Principal Investigator MS Clinical Phone Fax Designation Affiliation MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore , Karnataka Bangalore mukta.sachdev@mscr.in Details Contact Person (Scientific Query) Principal Investigator MS Clinical MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore , Karnataka Details Contact Person (Public Query) Phone Fax Designation Affiliation mukta.sachdev@mscr.in Details Contact Person (Public Query) Principal Investigator MS Clinical MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore , Karnataka page 1 / 7

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 Intervention / Comparator Agent Inclusion Criteria Phone Fax > Type of Sponsor List of Countries of Principal Investigator mukta.sachdev@mscr.in Source of Monetary or Material Support Primary Sponsor Details THE HIMALAYA DRUG COMPANY Makali, Bangalore , Karnataka, Pharmaceutical industry-n of Site Site Phone/Fax/ MS Clinical Research Pvt Ltd Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore , Karnataka Bangalore mukta.sachdev@mscr.i n of Committee Approval Status Date of Approval Is Independent Ethics Committee? Independent Ethics Committe- Aditya, Ahmedabad, Dr. Mukta Sachdev Status Health Type Healthy Human Volunteers Approved 17/01/2012 Yes Date No Date Specified Condition Apparent mild to moderate crow s feet in unanimated face Type Details Intervention Herbal anti wrinkle cream apply the provided Investigational product required quantity (app.0.5 gms) to cover the whole face twice daily (12 weeks per subject) Comparator Agent Placebo apply the provided Investigational product required quantity(app.0.5 gms) to cover the whole face twice daily(12 weeks per subject) Age From Age To Gender Details Year(s) Year(s) Female Inclusion Criteria Female subjects in generally good health Subjects of skin types III, IV, and V. page 2 / 7

3 Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Other Participant and Investigator Blinded Subjects age group years Subjects willing to give a written informed consent and come for a regular follow up. Subject willing to abide by and comply with the study protocol Subject has not participated in a similar investigation in the past four weeks. Subjects having visible fine lines and wrinkles in periorbital area (Crow s feet), nasolabial areas, forehead,and perioral regions of the face Subjects having mild to moderate nasolabial folds Subjects having apparent mild to moderate crow s feet in unanimated face Subjects who have not under gone any facial anti ageing procedures (e.g. Botulinum toxin, dermal filler injections, laser resurfacing) in the past 3 months. Subject should be willing to abstain from spa treatments/facials during the study period Exclusion Criteria A known history or present condition of allergic response to any cosmetic products. Subjects having severe photoaging. Subject having skin diseases (e.g. moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, active atopic dermatitis, melasma, lichen planus pigmentosus/ Achy dermatosis, pigmented contact dermatitis or other cutaneous manifestations), which will interfere with the test readings. Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study. Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy. Subjects not willing to discontinue other topical anti ageing, anti wrinkle facial products. Subjects who are pregnant, lactating or nursing. Hypersensitivity to any component of the tested products. History of intense sun exposure. Chronic illness which may influence the cutaneous state. Subject participating in any other cosmetic or therapeutic trial. Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness Primary Outcome Outcome Timepoints 1. Improvement by reduction in number and depth of facial wrinkles, finelines, nasolabial fold, crow s feet area in comparison to baseline. 2. Improvement by reduction in number and depth of facial wrinkles, finelines, nasolabial fold, crow s feet area in comparison to placebo Day 1, Day 28,Day 56 and Day 84 Secondary Outcome Outcome Timepoints Target Sample Size Total Sample Size=40 Sample Size from =40 page 3 / 7

4 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 01/03/2012 No Date Specified Years=0 Months=3 Days=0 Completed A Phase II, double blind placebo controlled, monocentric study to evaluate the efficacy an tolerance of herbal anti wrinkle cream in facial wrinkles of Healthy Human Subjects. a. Primary objectives To study product performance in reduction in number and depth of facial wrinkles, fine line nasolabial fold and crow s feet in comparison to baseline and placebo by followin parameters: Dermatologist s assessment Subject s self assessment Instrumental measurements- Visioscan and Visioline b. Secondary objective To study product performance in reduction of facial wrinkles in comparison t baseline and placebo by evaluating photographically apparent aging with Imaging system Image pro II Instrument measurement with corneometer to evaluate the moisturizatio effect in comparison to baseline and placebo Assessment for adverse events page 4 / 7

5 Double blind, placebo controlled, monocentric Total subjects (to compensate drop outs if any) Dermatologist s visual assessment Dermatologists assessments for adverse events Instrumental measurements- Visioscan, visioline & corneometer Assessment with Imaging system- Image pro II Subject s self assessment. Herbal anti wrinkle cream Placebo Healthy female subjects aged between years of skin type III, IV and V with faci wrinkles. Medical history, general physical examination, dermatological assessment Female subjects in generally good health page 5 / 7

6 Subjects of skin types III, IV, and V. Subjects age group years Subjects willing to give a written informed consent and come for a regular follo up. Subject willing to abide by and comply with the study protocol Subject has not participated in a similar investigation in the past four weeks. Subjects having visible fine lines and wrinkles in periorbital area (Crow s feet), nasolabial areas, forehead,and perioral regions of the face Subjects having mild to moderate nasolabial folds Subjects having apparent mild to moderate crow s feet in unanimated face Subjects who have not under gone any facial anti ageing procedures (e.g. Botulinum toxin, dermal filler injections, laser resurfacing) in the past 3 months. Subject should be willing to abstain from spa treatments/facials during the study period A known history or present condition of allergic response to any cosmet products. Subjects having severe photoaging. Subject having skin diseases (e.g. moderate to severe acne vulgaris face o nodulocystic acne, psoriasis, active atopic dermatitis, melasma, lichen planus pigmentosu Achy dermatosis, pigmented contact dermatitis or other cutaneous manifestations), which wi interfere with the test readings. Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromis the study. Systemic treatment which may modify the cutaneous state on the day of inclusio or in the previous 30 days, including retinoid therapy. Subjects not willing to discontinue other topical anti ageing, anti wrinkle faci products. Subjects who are pregnant, lactating or nursing. page 6 / 7

7 Powered by TCPDF ( PDF of Trial Hypersensitivity to any component of the tested products. History of intense sun exposure. Chronic illness which may influence the cutaneous state. Subject participating in any other cosmetic or therapeutic trial. Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness. 84 days (12 weeks) for each volunteer page 7 / 7

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