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

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

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.

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Drug: 3%Minoxidil lotion; Drug: 3% Minoxidil with 0.1% Finasteride lotion

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • Mae Fah Luang University Hospital(Bangkok)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minoxidil	Drug: 3%Minoxidil lotion; 3% Minoxidil lotion apply two times a day
Active Comparator: MinoxidilFinasteride	Drug: 3% Minoxidil with 0.1% Finasteride lotion; 3% Minoxidil with 0.1% Finasteride lotion apply two times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mae Fah Luang University Hospital
• Investigators: Principal Investigator: Chuchai Tanglertsampan, MD, Mae Fah Luang University Hospital(Bangkok)

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: July 1, 2011
• First Submitted That Met QC Criteria: July 7, 2011
• First Posted (Estimate): July 11, 2011

Study Record Updates

• Last Update Posted (Estimate): July 20, 2012
• Last Update Submitted That Met QC Criteria: July 19, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: topical; androgenetic alopecia; male pattern hair loss; finasteride; minoxidil; lotion
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Finasteride; Minoxidil
• Other Study ID Numbers: REH-54015