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

Primary Purpose

Androgenetic Alopecia

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
3%Minoxidil lotion
3% Minoxidil with 0.1% Finasteride lotion
Sponsored by
Mae Fah Luang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring minoxidil, finasteride, topical, lotion, male pattern hair loss, androgenetic alopecia

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mae Fah Luang University Hospital(Bangkok)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Minoxidil

MinoxidilFinasteride

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 1, 2011
Last Updated
July 19, 2012
Sponsor
Mae Fah Luang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01391156
Brief Title
Efficacy Study of Minoxidil Lotion Versus Combined Minoxidil and Finasteride Lotion to Treat Male Pattern Hair Loss
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mae Fah Luang University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
minoxidil, finasteride, topical, lotion, male pattern hair loss, androgenetic alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minoxidil
Arm Type
Experimental
Arm Title
MinoxidilFinasteride
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
3%Minoxidil lotion
Intervention Description
3% Minoxidil lotion apply two times a day
Intervention Type
Drug
Intervention Name(s)
3% Minoxidil with 0.1% Finasteride lotion
Intervention Description
3% Minoxidil with 0.1% Finasteride lotion apply two times a day.
Primary Outcome Measure Information:
Title
The mean change of hair count from baseline and 6 months
Description
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.
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
Global photographic assessment by dermatologists
Description
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.
Time Frame
baseline and 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chuchai Tanglertsampan, MD
Organizational Affiliation
Mae Fah Luang University Hospital(Bangkok)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mae Fah Luang University Hospital(Bangkok)
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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