Clinical Trial for Evaluation of Efficacy and Safety of Fixed Dose Combination of Minoxidil + Finasteride Solution in Comparison with Minoxidil Solution in Adult Male Patients with Androgenic Alopecia
- Conditions
- Androgenic alopecia
- Registration Number
- CTRI/2009/091/000896
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
The proposed trial is intended for comparing the efficacy and safety of fixed dose combination of Minoxidil (5%) + Finasteride (0.1%) lipid solution with Minoxidil (5%) solution in adult male patients with androgenic alopecia. In view of the different mechanisms of action, it is hypothesized that the simultaneous administration of both the molecules should have a synergistic action. The side effects associated with the oral administration would also be reduced. If the dosage of the individual drug could be reduced, it will further improve the safety profile of the therapy. It is also expected that topical administration of finasteride will reduce the systemic exposure of finasteride leading to less adverse effect on the reproductive system i.e. less incidence of loss of libido, erectile dysfunction, ejaculation disorders, breast engorgement or tenderness and effects on testis (pain in testis, hormonal effects etc.). These events are important especially in young and middle aged males as they might demoralize the patient to undergo finasteride treatment for the AGA. The trial will be conducted in Indian patients within India only. First patient enrolment in the study is anticipated in the second week of February, 2010.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 270
Inclusion Criteria: (1) Male 18 to 45 years of age, with androgenic alopecia with II to V grade on the modified Norwood Hamilton classification (2) Willingness to maintain the same hair style, approximate length, and hair color throughout the study (3) Subjects willing to provide written informed consent.
(1) Concomitant dermatological disorders on the scalp (2) Serious cardiovascular diseases, renal diseases or hepatic diseases(3) History of drug hypersensitivity, breast disorders or testicular disorders (4) Wearing a wig or under gone surgical treatment for hair loss (5) Shaved scalp or undergoing topical scalp treatment(6) Clinically significant abnormalities on physical examination or laboratory tests(7) History of medication interfering with the study objectives(8) Ongoing use of prohibited medications.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the investigator assessment score for hair growth and scalp coverage Each visit from enrollment onwards
- Secondary Outcome Measures
Name Time Method (1)Patients assessment of hair growth and loss by hair growth questionnaire. (2)Change in global photographic assessment for hair growth by 7 point scale.
Trial Locations
- Locations (15)
Ankur Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Centre for Skin Diseases, Skin Surgery, Cosmetology & Laser Treatments
🇮🇳Bhopal, MADHYA PRADESH, India
Dr. (Mrs.) Meena B. Makhecha
🇮🇳Mumbai, MAHARASHTRA, India
Dr. Bharat I. Lalwala
🇮🇳Surat, GUJARAT, India
Dr. Girish H. Shah
🇮🇳Takshashila, India
Dr. Janak K. Thakkar
🇮🇳Rajkot, GUJARAT, India
Dr. Kelkar's Skin Clinic
🇮🇳Pune, MAHARASHTRA, India
Dr. Sushil T. Tahaliani
🇮🇳Mumbai, MAHARASHTRA, India
Dr. Umesh K. Nihalani
🇮🇳Ahmadabad, GUJARAT, India
Gala Skin & Hair Clinic
🇮🇳Mumbai, MAHARASHTRA, India
Scroll for more (5 remaining)Ankur Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr. Siddhi B. ChikhalkarPrincipal investigator022-25662122