Back to resultsMinoxidil 2% for Eyebrow Enhancement
Primary Purpose
Hypotrichosis of Eyebrows, Thinning Eyebrows
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Minoxidil lotion 2%
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypotrichosis of Eyebrows focused on measuring hypotrichosis of eyebrows, thinning eyebrows, minoxidil, placebo, randomized
Eligibility Criteria
Inclusion Criteria:
- male or female aged 18-40 years
- hypotrichosis of eyebrows
- healthy
- informed consent obtained
Exclusion Criteria:
- no underlying diseases
- no alopecia areata or trichotillomania
- no thyroid diseases
- no pregnancy or breast feeding
- no previous eyebrow tattoo, trauma or accident.
- no history of eyebrow or hair medications in 6 months
- no history of minoxidil or its ingredient allergy
- no history of eyebrow surgery.
Sites / Locations
- MFL University Hospital (Bangkok)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Minoxidil lotion 2%
Placebo
Arm Description
Minoxidil lotion 2% is applied twice daily to one eyebrow.
Placebo is applied twice daily to the other eyebrow.
Outcomes
Primary Outcome Measures
The change of global photographic assessment after 16 weeks from baseline
Secondary Outcome Measures
The change of hair diameter after 16 weeks from baseline
Full Information
NCT ID
NCT01672307
First Posted
August 19, 2012
Last Updated
June 18, 2013
Sponsor
Mae Fah Luang University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01672307
Brief Title
Minoxidil 2% for Eyebrow Enhancement
Official Title
Efficacy and Tolerability of Minoxidil 2% for Eyebrow Enhancement : A Randomized , Double-blind , Placebo-controlled , Split-face Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mae Fah Luang University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to compare minoxidil 2% versus placebo in enhancement of eyebrows.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotrichosis of Eyebrows, Thinning Eyebrows
Keywords
hypotrichosis of eyebrows, thinning eyebrows, minoxidil, placebo, randomized
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minoxidil lotion 2%
Arm Type
Experimental
Arm Description
Minoxidil lotion 2% is applied twice daily to one eyebrow.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is applied twice daily to the other eyebrow.
Intervention Type
Drug
Intervention Name(s)
Minoxidil lotion 2%
Intervention Description
Minoxidil lotion 2% is applied twice daily to one eyebrow.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is applied twice daily to the other eyebrow.
Primary Outcome Measure Information:
Title
The change of global photographic assessment after 16 weeks from baseline
Time Frame
baseline and 16 weeks
Secondary Outcome Measure Information:
Title
The change of hair diameter after 16 weeks from baseline
Time Frame
baseline and 16 weeks
Other Pre-specified Outcome Measures:
Title
The change in number of hairs after 16 weeks from baseline
Time Frame
baseline and 16 weeks
Title
Number of participants with adverse events. Adverse events include any skin rashes or symptoms.
Time Frame
16 weeks
Title
Patient satisfaction by self-assessment questionnaires
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
male or female aged 18-40 years
hypotrichosis of eyebrows
healthy
informed consent obtained
Exclusion Criteria:
no underlying diseases
no alopecia areata or trichotillomania
no thyroid diseases
no pregnancy or breast feeding
no previous eyebrow tattoo, trauma or accident.
no history of eyebrow or hair medications in 6 months
no history of minoxidil or its ingredient allergy
no history of eyebrow surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chuchai Tanglertsampan, MD
Organizational Affiliation
MFL University Hospital (Bangkok)
Official's Role
Principal Investigator
Facility Information:
Facility Name
MFL University Hospital (Bangkok)
City
Bangkok
ZIP/Postal Code
10110
Country
Thailand
12. IPD Sharing Statement
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Minoxidil 2% for Eyebrow Enhancement
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