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Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement

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ClinicalTrials.gov Identifier: NCT02275832
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
Chuchai TANGLERTSAMPAN, MD, Mae Fah Luang University Hospital

Tracking Information
First Submitted Date  ICMJE October 23, 2014
First Posted Date  ICMJE October 27, 2014
Last Update Posted Date April 22, 2015
Study Start Date  ICMJE November 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2014)
The change of global photographic assessment after 16 weeks from baseline [ Time Frame: baseline and 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2014)
The change in number of hairs after 16 weeks from baseline [ Time Frame: baseline and 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 24, 2014)
  • The change of hair diameter after 16 weeks from baseline [ Time Frame: baseline and 16 weeks ]
  • Number of participants with adverse events [ Time Frame: baseline and 16 weeks ]
  • Patient satisfaction by self-assessment questionnaires [ Time Frame: baseline and 16 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement
Official Title  ICMJE Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement : A Randomized, Double-blind, Placebo-controlled Study
Brief Summary The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for beard enhancement.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Beard Enhancement
Intervention  ICMJE
  • Drug: 3 % Minoxidil lotion
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Minoxidil
    3% Minoxidil lotion is applied twice daily to the beard.
    Intervention: Drug: 3 % Minoxidil lotion
  • Placebo Comparator: Placebo
    Placebo is applied twice daily to beard.
    Intervention: Drug: Placebo
Publications *

*   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: April 21, 2015)
48
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2014)
64
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male

Exclusion Criteria:

  • serious underlying diseases.
  • history of beard/ hair treatment before 6 months
  • history of surgery or trauma on beard area.
  • history of minoxidil allergy
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT02275832
Other Study ID Numbers  ICMJE REH-57077
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 MFL University Hospital (Bangkok)
PRS Account Mae Fah Luang University Hospital
Verification Date April 2015

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