None listed
Conditions
Interventions
Intervention1: 1.5% Aminexil +5% Minoxidil Topical Solution: Solution applied Twice daily for 24 weeks
Control Intervention1: 5% Minoxidil topical solution: Solution applied twice daily for 24 weeks
Sponsors
Glenmark Pharmaceuticals Ltd
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluation of hair density using Trichoscan. 2. Evaluation of A/T ratio using Trichoscan. 3. Biopsy on 30 volunteers to evaluate perifollicular fibrosis. 4. Expert panel (of 3) comparative grading of photographs versus baseline using a 7 point rating scale 5. Comparative grading of photographs versus baseline using a 6 point rating scale by Subjects 6. Cosmetic acceptability Form.Timepoint: Visit 2, 4 & 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of in use safety of the test product. ? Dermatological tolerance evaluation ? Blood test (haemoglobin, total leucocyte count, differential leucocyte count, total RBC count, platelet count & ESR.SGOT, SGPT, and total bilirubin, alkaline phosphatase, random blood sugar, serum creatinine, BUN & serum electrolytes).Timepoint: Visit 2, 3, 4, 5 & 6 | — |
Countries
India
Contacts
Public ContactDr Chandrashekhar Bolmall
Outcome results
None listed