How effective is Minoxidil combined with either oral or local application of finasteride in men with baldness
- Conditions
- Male patients with Grade II-IV androgenetic alopecia
- Registration Number
- CTRI/2017/03/008250
- Lead Sponsor
- Medical College Kolkata
- Brief Summary
**Objectiveof proposed research :**Assessment of effectiveness of topical minoxidil 5%+finasteride 0.1% fixed-dosecombination versus topical minoxidil 5% and oral finasteride 1mg/day in androgeneticalopecia grade II-IV
**Backgroundof present study:** Androgeneticalopecia is a disease of hair loss affecting adult males and some females. Itis measured in Hamilton Norwood Scale. It affects quality of life. The majorrole is played by dihydrotestosterone . Minoxidil (an antihypertensive) usedtopically, and finasteride, a 5 alpha reductase inhibitor used orally areeffective. A combination of both is the presently followed protocol.Combination of topical forms is likely to have better compliance and be a moreacceptable form of therapy and hence can reduce disease burden.
**Methodology:** This is aninstitution based randomised double blind clinical trial where patients in theout-patients department will be screened as per criteria, randomised, andfollowed up monthly for six months to see the outcome based on Hamilton-Norwoodscale. Males of 18-45 years age, with alopecia grade II-IV will beincluded. Improvement will be measuredby Hamilton-Norwood scale, subject’s self assessment and investigator’sassessment of hair growth, and patient’s and physician’s global assessment ofdisease activity improvement. Digital photographs will be taken to assesschanges. Analysis will be done.
**Expectedoutcome:** Weexpect to find out the clinical improvement in both the groups of study whereimprovement means 1)Improvement in Hamilton Norwood scale 2) Change in the subject’sself assessment of hair growth 3) Change in the investigator’s assessment ofhair growth 4) Patient’s global assessment of disease activity improvement 5)Physician’s global assessment of disease activity improvement. We will also monitorany side effects and improvement in patient’s quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Male
- Target Recruitment
- 72
- Age 18-45 years 2.
- Sex: Male 3.
- Hamilton-Norwood scale grade II-IV 4.
- Informed consent obtained 5.
- Willing for follow up 6.
- Willing to agree to maintain same hair style, use same shampoo, and not to cut hair shorter than 1 inch length.
- Treated with minoxidil/finasteride within last 1 month 2.
- Co-morbidities like diabetes, hypertension, thyroid disorder, heart disease, hepatic/kidney dysfunction 3.
- Immunosuppression in any form 4.
- Other dermatological scalp disorders 5.
- History of drug hypersensitivity, breast disorder, testicular disorder.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of hair regrowth using Hamilton-Norwood Scale baseline, 6th follow up at end of 6 months treatment
- Secondary Outcome Measures
Name Time Method Investigator’s assessment of hair growth (5 point scale) baseline, monthly for next 6 follow ups Any side effect detected by physician at all follow ups Any symptoms complained of by patient at all monthly follow ups for 6 months Quality of life in patients will be assessed by a validated vernacular version of Dermatology Life Quality Index (DLQI) baseline, 6th follow up at end of 6 months treatment Subjects’ self assessment of hair growth (5 point scale) at all monthly follow ups for 6 months Patient’s global assessment of disease activity improvement (5 point Likert scale) at all monthly follow ups for 6 months
Trial Locations
- Locations (1)
Medical College, Kolkata
🇮🇳Kolkata, WEST BENGAL, India
Medical College, Kolkata🇮🇳Kolkata, WEST BENGAL, IndiaRamesh Chandra GharamiPrincipal investigator9434173114rameshgharami8@gmail.com