To study and compare the tolerance of 2 test products in bald men.
- Conditions
- Health Condition 1: null- Androgenetic alopecia (Baldness)
- Registration Number
- CTRI/2011/11/002128
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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.Alopecia areata, alopecia totalis, alopecia universalis and alopecia diffusa.
2.Scarring of the scalp or any other condition or disease of the scalp or hair, including diseases of the hair shaft and inability to discontinue use of hair weaving.
3.Volunteers with any cardiac abnormalities or ailments or abnormal blood pressure.
4.Use of the following during the 6 months prior to screening:
a.Minoxidil (oral or topical)
b.Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide). Cimetidine cannot be used during the study but is not an excluded drug when used during the previous 6 months.
c.Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens).
d.Anabolic steroids.
e.Lithium and phenothiazines.
5.Use of systemic steroids for more than 14 days within the past 2 months prior to enrollment in the study.
6.Use of isotretinoin, radiation to the scalp, or chemotherapy within the past year.
7.Known sensitivity to the investigational product.
8.Hypersensitivity to any cosmetic product, raw material.
9.Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
10.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
11.Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial on Visit 1.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Evaluation of in use tolerance of Products via self evaluation Questionnaire. <br/ ><br>â?¢Dermatological evaluation of in use tolerance. <br/ ><br>Timepoint: â?¢Evaluation of in use tolerance of Products via self evaluation Questionnaire. <br/ ><br>â?¢Dermatological evaluation of in use tolerance. <br/ ><br>Tolerance of the product will be examined after day 45 (last visit) <br/ ><br>
- Secondary Outcome Measures
Name Time Method â?¢Evaluation using Phototrichogram (TrichoScan).Timepoint: Baseline and day 45