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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014