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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chuchai TANGLERTSAMPAN, MD, Mae Fah Luang University Hospital
ClinicalTrials.gov Identifier:
NCT01391156
First received: July 1, 2011
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Androgenetic Alopecia
 Drug: 3%Minoxidil lotion
Drug: 3% Minoxidil with 0.1% Finasteride lotion
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mae Fah Luang University Hospital:

Primary Outcome Measures:
  • The mean change of hair count from baseline and 6 months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01391156

Locations
Thailand
Mae Fah Luang University Hospital(Bangkok)
Bangkok, Thailand
Sponsors and Collaborators
Mae Fah Luang University Hospital
Investigators
Principal Investigator: Chuchai Tanglertsampan, MD Mae Fah Luang University Hospital(Bangkok)
  More Information

No publications provided

Responsible Party: Chuchai TANGLERTSAMPAN, MD, Chuchai Tanglertsampan, MD, Mae Fah Luang University Hospital
ClinicalTrials.gov Identifier: NCT01391156     History of Changes
Other Study ID Numbers: REH-54015
Study First Received: July 1, 2011
Last Updated: July 19, 2012
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Mae Fah Luang University Hospital:
minoxidil
finasteride
topical
 lotion
male pattern hair loss
androgenetic alopecia

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Finasteride
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013