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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2012

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Minoxidil
  • Active Comparator: MinoxidilFinasteride

Clinical Trial Outcome Measures

Primary Measures

  • The mean change of hair count from baseline and 6 months
    • Time Frame: 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.

Secondary Measures

  • Global photographic assessment by dermatologists
    • Time Frame: baseline and 6 months
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mae Fah Luang University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chuchai TANGLERTSAMPAN, MD, Chuchai Tanglertsampan, MD – Mae Fah Luang University Hospital
  • Overall Official(s)
    • Chuchai Tanglertsampan, MD, Principal Investigator, Mae Fah Luang University Hospital(Bangkok)

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