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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01391156
Recruitment Status : Completed
First Posted : July 11, 2011
Last Update Posted : July 20, 2012
Sponsor:
Information provided by (Responsible Party):
Chuchai TANGLERTSAMPAN, MD, Mae Fah Luang University Hospital

Tracking Information
First Submitted Date  ICMJE July 1, 2011
First Posted Date  ICMJE July 11, 2011
Last Update Posted Date July 20, 2012
Study Start Date  ICMJE March 2011
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01391156 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Minoxidil Lotion Versus Combined Minoxidil and Finasteride Lotion to Treat Male Pattern Hair Loss
Official Title  ICMJE Efficacy of 3% Minoxidil Versus Combined 3% Minoxidil and 0.1% Finasteride for Male Pattern Hair Loss: a Randomized, Double-blinded, Comparative Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Androgenetic Alopecia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Minoxidil
    Intervention: Drug: 3%Minoxidil lotion
  • Active Comparator: MinoxidilFinasteride
    Intervention: Drug: 3% Minoxidil with 0.1% Finasteride lotion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2011)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01391156
Other Study ID Numbers  ICMJE REH-54015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chuchai TANGLERTSAMPAN, MD, Mae Fah Luang University Hospital
Study Sponsor  ICMJE Mae Fah Luang University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chuchai Tanglertsampan, MD Mae Fah Luang University Hospital(Bangkok)
PRS Account Mae Fah Luang University Hospital
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP