A clinical trial to study the effect of a test product kit containing 4 test products (Hair Forever SLS Free Shampoo, Hair Forever Growth Enhancer Gel, Hair Forever LLP Free Nourishing & Revitalizing oil and Hair Forever Scalp Essential pack) in men with Androgenetic Alopecia.
- Registration Number
- CTRI/2010/091/002817
- Lead Sponsor
- TVC Sky Shop Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
1.Voluntary men suffering from androgenetic alopecia grade 2 vertex, 3 and 4.
2.Age: 18 to 55 years.
3.Not having done any cosmetic hair treatments i.e. coloring, bleaching, and henna, etc for last 1 month.
4.Has been fully informed verbally and in writing to comply with the study specifications.
5.Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
6.Presenting healthy scalp.
7.Accepting not to use products with same end benefit, during the study.
8.Cooperating, informed of the need and duration of the examinations.
9.For which the investigator considers that the compliance will be correct.
1. Cutaneous illness, localized on tested areas, which could interfere with the clinical evaluation.
2. History of allergic dermatitis to cosmetics or hair care products.
3. Subjects taking treatment for hair fall
?local - during last 1month
?or using minoxidil during last 3 months
?and systemic - during last 3 months
4. Subjects on any other local (during last 1month) or systemic (during last 3 months) medical treatment that could interfere with hair growth or hair loss e.g. vasodilators, steroids etc.
5. Haemoglobin less than 10 g/dl by blood test
6. Subjects with history of medical/surgical events that may significantly affect the study outcome e.g. h/o typhoid or jaundice etc.
7. Hyper sensitivity to any component of the tested product,
8. Volunteers exposed to intense sunlight.
9. Any acute or chronic disease.
10. Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Primary Evaluation criteria (Primary Objective) for this study: <br/ ><br>- Evaluation of Anagen-Telogen ratio using Phototrichogram (TrichoScan). <br/ ><br>Timepoint: Day 4, Visit 90, Visit 180;The Primary Evaluation criteria (Primary Objective) for this study: <br/ ><br>- Evaluation of Anagen-Telogen ratio using Phototrichogram (TrichoScan). <br/ ><br>Timepoint: Day 4, Visit 90, Visit 180;The Primary Evaluation criteria (Primary Objective) for this study: <br/ ><br>- Evaluation of Anagen-Telogen ratio using Phototrichogram (TrichoScan). <br/ ><br>Timepoint: Day 4, Visit 90, Visit 180
- Secondary Outcome Measures
Name Time Method Clinical Evaluation for Tolerance of the test product on scalp.Timepoint: Day 87, Day 177