Efficacy Study of Minoxidil Lotion Versus Combined Minoxidil and Finasteride Lotion to Treat Male Pattern Hair Loss

Androgenetic Alopecia Clinical Trial

Official title:

Efficacy of 3% Minoxidil Versus Combined 3% Minoxidil and 0.1% Finasteride for Male Pattern Hair Loss: a Randomized, Double-blinded, Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391156
• Other study ID #: REH-54015
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2011
• Last updated: July 19, 2012
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2012
• Source: Mae Fah Luang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy of 3% Minoxidil lotion and 3% Minoxidil with 0.1% Finasteride lotion for 6 months in male pattern hair loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• male, age 18-15 years

• androgenetic alopecia grade 3V to 5 ( Norwood-Hamilton classification)

Exclusion Criteria:

• use minoxidil in 6 months

• use finasteride in 12 months

• use ketoconazole, tar, selenium shampoo, topical tretinoin, topical steroid in 2 weeks

• seborrheic dermatitis or psoriasis on scalp

• history of allergy to minoxidil, finasteride

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Androgenetic Alopecia

Intervention

Drug:
• 3%Minoxidil lotion
3% Minoxidil lotion apply two times a day
• 3% Minoxidil with 0.1% Finasteride lotion
3% Minoxidil with 0.1% Finasteride lotion apply two times a day.

Locations

Country	Name	City	State
Thailand	Mae Fah Luang University Hospital(Bangkok)	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mae Fah Luang University Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean change of hair count from baseline and 6 months	Total hair count on the vertex is measured on 1 cm2 circular area. The mean change in hair count is compared at baseline and 6 months.The significance of change is determined by Unpaired t Test.	baseline and 6 months	No
Secondary	Global photographic assessment by dermatologists	Photographs of the vertex scalp are taken at baseline and 6 months. A panel of 3 dermatologists assesssed the change in hair growth using a 7-point scale.	baseline and 6 months	No