Objective of proposed research : Assessment of effectiveness of topical minoxidil 5%+finasteride 0.1% fixed-dose combination versus topical minoxidil 5% and oral finasteride 1mg/day in androgenetic alopecia grade II-IV

Background of present study: Androgenetic alopecia is a disease of hair loss affecting adult males and some females. It is measured in Hamilton Norwood Scale. It affects quality of life. The major role is played by dihydrotestosterone . Minoxidil (an antihypertensive) used topically, and finasteride, a 5 alpha reductase inhibitor used orally are effective. A combination of both is the presently followed protocol. Combination of topical forms is likely to have better compliance and be a more acceptable form of therapy and hence can reduce disease burden.

Methodology : This is an institution based randomised double blind clinical trial where patients in the out-patients department will be screened as per criteria, randomised, and followed up monthly for six months to see the outcome based on Hamilton-Norwood scale. Males of 18-45 years age, with alopecia grade II-IV will be included.  Improvement will be measured by Hamilton-Norwood scale, subject’s self assessment and investigator’s assessment of hair growth, and patient’s and physician’s global assessment of disease activity improvement. Digital photographs will be taken to assess changes. Analysis will be done.

Expected outcome: We expect to find out the clinical improvement in both the groups of study where improvement means 1)Improvement in Hamilton Norwood scale 2) Change in the subject’s self assessment of hair growth 3) Change in the investigator’s assessment of hair growth 4) Patient’s global assessment of disease activity improvement 5) Physician’s global assessment of disease activity improvement. We will also monitor any side effects and improvement in patient’s quality of life.