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
- Health Condition 1: null- Androgenic alopecia
- Registration Number
- CTRI/2009/091/000896
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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 coverageTimepoint: Each visit from enrollment onwards
- Secondary Outcome Measures
Name Time Method (1)Patients assessment of hair growth and loss by hair growth questionnaire. <br/ ><br>(2)Change in global photographic assessment for hair growth by 7 point scale. <br/ ><br>(3)Any adverse event reported voluntarily, observed or enquired. <br/ ><br>(4)Any clinically significant change in the value of laboratory, vital signs and physical examination compared to baseline.Timepoint: (1)Each visit from first follow-up onwards. <br/ ><br>(2)Baseline, at end of 12 weeks and at the end of study visit. <br/ ><br>(3)Each visit from enrollment onwards. <br/ ><br>(4)Each visit from enrollment onwards.