Randomized double-blind study of efficacy and safety of topical 3% minoxidil solution combined with 0.25% finasteride solution versus 3% minoxidil solution in treatment of male androgenetic alopecia

• Register: TCTR
• Last refreshed on: 1 April 2024
• Main ID: TCTR20160910002
• Date of registration: 10/09/2016
• Prospective Registration: No
• Primary sponsor: Division of Dermatology, Ramathibodi Hospital, Mahidol University
• Public title: Randomized double-blind study of efficacy and safety of topical 3% minoxidil solution combined with 0.25% finasteride solution versus 3% minoxidil solution in treatment of male androgenetic alopecia
• Scientific title: Randomized double-blind study of efficacy and safety of topical 3% minoxidil solution combined with 0.25% finasteride solution versus 3% minoxidil solution in treatment of male androgenetic alopecia
• Date of first enrolment: 23/06/2015
• Target sample size: 40
• Recruitment status: Completed
• URL: https://www.thaiclinicaltrials.org/show/TCTR20160910002
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 3

Countries of recruitment

Thailand

Contacts

• Name: Poonkiat Suchonwanit
• Affiliation: Ramathibodi Hospital, Mahidol University

• Name: Poonkiat Suchonwanit
• Affiliation: Ramathibodi Hospital, Mahidol University

Key inclusion & exclusion criteria

Inclusion criteria: 1.Healthy male subject
2.Diagnosis of androgenic alopecia with class III and V Norwood-Hamilton classification
3.Agree to participate and signed informed consent form
Exclusion criteria: 1.History of hair transplant
2.Applying topical hair growth products within 2 weeks
3.Receiving light and laser treatment of the scalp within 3 months
4.Taking oral finasteride within 12 months
5.Taking dutasteride within 18 months
6.History of systemic illness
7.History of scalp diseases eg. seborrheic dermatitis, scalp infection.

Age minimum: 18 Years
Age maximum: 0 N/A (No limit)
Gender: Male

Health Condition(s) or Problem(s) studied

Androgenetic alopecia
Male pattern alopecia
Male pattern baldness

Androgenetic alopecia
Androgenetic alopecia
Male pattern alopecia
Male pattern baldness

Intervention(s)

Topical 3% minoxidil solution combined with 0.25% finasteride solution,Topical 3% minoxidil solution

Experimental Drug,Active Comparator Drug

Primary Outcome(s)

Efficacy of topical 3% minoxidil solution combined with 0.25% finasteride solution 6 months Hair count and hair diameter

Secondary Outcome(s)

Safety of topical 3% minoxidil solution combined with 0.25% finasteride solution 6 months Erythema, Scaliness, Inflammation and Systemic side effects

Source(s) of Monetary Support

Division of Dermatology, Ramathibodi Hospital, Mahidol University

Secondary Sponsor(s)

Division of Dermatology, Ramathibodi Hospital, Mahidol University

Ethics review

Status: Submitted, approved
Approval date:
Contact:

[e-mail]

Committee on Human Rights Related to Research Involving Human Subjects

02-2011544 Ext.

[e-mail]

Results

• Date Completed: 25/03/2016