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Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement

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: 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

Study Description
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Brief Summary:
The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for beard enhancement.

Condition or disease Intervention/treatment Phase
Beard Enhancement Drug: 3 % Minoxidil lotion Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement : A Randomized, Double-blind, Placebo-controlled Study
Study Start Date : November 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

Arms and Interventions
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Arm Intervention/treatment
Experimental: Minoxidil
3% Minoxidil lotion is applied twice daily to the beard.
 Drug: 3 % Minoxidil lotion
Placebo Comparator: Placebo
Placebo is applied twice daily to beard.
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. The change of global photographic assessment after 16 weeks from baseline [ Time Frame: baseline and 16 weeks ]

Secondary Outcome Measures :
  1. The change in number of hairs after 16 weeks from baseline [ Time Frame: baseline and 16 weeks ]

Other Outcome Measures:
  1. The change of hair diameter after 16 weeks from baseline [ Time Frame: baseline and 16 weeks ]
  2. Number of participants with adverse events [ Time Frame: baseline and 16 weeks ]
  3. Patient satisfaction by self-assessment questionnaires [ Time Frame: baseline and 16 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275832


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

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Responsible Party: Chuchai TANGLERTSAMPAN, MD, Assitant Professor, Mae Fah Luang University Hospital
ClinicalTrials.gov Identifier: NCT02275832    
Other Study ID Numbers: REH-57077
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Minoxidil
Antihypertensive Agents
Vasodilator Agents