A clinical trial to study the efficacy and tolerability of a combination of two topical drugs, minoxidil and aminexil in patients with male pattern hair loss

Phase 4

• Registration Number: CTRI/2009/091/001073
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 204

Inclusion Criteria

1. Male patients of age between 18 to 50.
2. Presence of androgenetic alopecia based on the Norwood Hamilton Scale grade 3 and 4 with
vertex involvement (Appendix B).
3. Accepting not to use products with the same end benefit during the entire study duration.
4. For whom the Investigator considers that the compliance will be correct.
5. Cooperating, informed of the need and duration of the examinations, and ready to comply with
protocol procedures.
6. Having signed a Consent Form and will be once informed orally and in writing of all information
concerning the study procedures and study objectives.

Exclusion Criteria

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:
? Minoxidil (oral or topical)
? 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.
? Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens)
? Anabolic steroids
? 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified