Randomised, double blind clinical trial to assess the effectiveness of topical minoxidil (5%) and topical finasteride (0.1%) fixed-dose combination versus topical minoxidil (5%) and oral finasteride (1 mg/day) in grade II-IV androgenetic alopecia: a pilot study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Medical College Kolkata
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Assessment of hair regrowth using Hamilton-Norwood Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Age 18-45 years
- •Sex: Male
- •Hamilton-Norwood scale grade II-IV
- •Informed consent obtained
- •Willing for follow up
- •Willing to agree to maintain same hair style, use same shampoo, and not to cut hair shorter than 1 inch length.
Exclusion Criteria
- •Treated with minoxidil/finasteride within last 1 month
- •Co-morbidities like diabetes, hypertension, thyroid disorder, heart disease, hepatic/kidney dysfunction
- •Immunosuppression in any form
- •Other dermatological scalp disorders
- •History of drug hypersensitivity, breast disorder, testicular disorder.
Outcomes
Primary Outcomes
Assessment of hair regrowth using Hamilton-Norwood Scale
Time Frame: baseline, 6th follow up at end of 6 months treatment
Secondary Outcomes
- Investigator’s assessment of hair growth (5 point scale)(baseline, monthly for next 6 follow ups)
- Any symptoms complained of by patient(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)
- Any side effect detected by physician(at all follow ups)
- 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)