Effectiveness and safety of topical 5 % minoxidil versus combination of 5% minoxidil and 0.1% finasteride in male pattern hair loss: A randomized, comparative, evaluator blinded study
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- The three primary efficacy and safety outcome measures will be the change in total and terminal hair count, scoring of the global photographs by blinded evaluators and adverse events, assessed in both the groups
Study Overview
Brief Summary
This is an interventional, prospective, randomised, comparative, parallel group, evaluator -blinded therapeutic trial, including 160 male patients aged 18 to 45 years with clinically diagnosed male pattern hair loss, to compare the effectiveness and safety of application of topical minoxidil 5% only twice daily in 80 patients versus topical combination of minoxidil 5% and finasteride 0.1% twice daily in 80 patients for a period of 12 months in one centre in India. The primary outcome measures will be the total and terminal hair counts, global photograph scoring by blinded evaluators and adverse events assessed in both groups at 3 monthly intervals for a period of one year. the secondary outcome measure will be the subjective improvement assessment by the patients.
Study Design
- Study Type
- Interventional
- Allocation
- Random Number Table
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Patients with clinical diagnosis of male pattern baldness with Modified Norwood-Hamilton grading III vertex, IV and V
- •Duration of hair loss less than 5 years.
Exclusion Criteria
- •Any systemic or topical treatment for hair loss in last 6 months
- •Any significant cardiovascular diseases like coronary artery disease, congestive heart failure, cardiac dysrhythmias or valvular disease
- •Unrealistic expectations.
Outcomes
Primary Outcomes
The three primary efficacy and safety outcome measures will be the change in total and terminal hair count, scoring of the global photographs by blinded evaluators and adverse events, assessed in both the groups
Time Frame: 12 weekly
Secondary Outcomes
- The secondary efficacy outcome measure will be the patients subjective hair growth assessment score.(12 weekly)