A clinical trial to study the effect of topical minoxidil 5% solution alone and a combination topical minoxidil 5% and finasteride 0.1% solution for the treatment of common baldness in men

Phase 4

Recruiting

• Conditions: Male pattern hair loss

• Registration Number: CTRI/2017/10/010054
• Lead Sponsor: Government Medical College and Hospital Sector Chandigarh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-09
• Last Update Posted: 2017-10-10

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Male
• Target Recruitment: 160

Inclusion Criteria

• Patients with clinical diagnosis of male pattern baldness with Modified Norwood-Hamilton grading III vertex, IV and V 2.
• Duration of hair loss less than 5 years.

Exclusion Criteria

• Any systemic or topical treatment for hair loss in last 6 months 2.
• Any significant cardiovascular diseases like coronary artery disease, congestive heart failure, cardiac dysrhythmias or valvular disease 3.
• Unrealistic expectations.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	12 weekly

Secondary Outcome Measures

Name	Time	Method
The secondary efficacy outcome measure will be the patients subjective hair growth assessment score.	12 weekly

Trial Locations

Locations (1)

Government Medical College and Hospital, Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

Government Medical College and Hospital, Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Dr Jasleen Kaur

Principal investigator

9646481249

jasleenksandhu21@gmail.com