- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01672307
Minoxidil 2% for Eyebrow Enhancement
June 18, 2013 updated by: Chuchai TANGLERTSAMPAN, MD, Mae Fah Luang University Hospital
Efficacy and Tolerability of Minoxidil 2% for Eyebrow Enhancement : A Randomized , Double-blind , Placebo-controlled , Split-face Comparative Study
The purpose of the study is to compare minoxidil 2% versus placebo in enhancement of eyebrows.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bangkok, Thailand, 10110
- MFL University Hospital (Bangkok)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo is applied twice daily to the other eyebrow.
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Placebo is applied twice daily to the other eyebrow.
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Experimental: Minoxidil lotion 2%
Minoxidil lotion 2% is applied twice daily to one eyebrow.
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Minoxidil lotion 2% is applied twice daily to one eyebrow.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change of global photographic assessment after 16 weeks from baseline
Time Frame: baseline and 16 weeks
|
baseline and 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change of hair diameter after 16 weeks from baseline
Time Frame: baseline and 16 weeks
|
baseline and 16 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change in number of hairs after 16 weeks from baseline
Time Frame: baseline and 16 weeks
|
baseline and 16 weeks
|
Number of participants with adverse events. Adverse events include any skin rashes or symptoms.
Time Frame: 16 weeks
|
16 weeks
|
Patient satisfaction by self-assessment questionnaires
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chuchai Tanglertsampan, MD, MFL University Hospital (Bangkok)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
August 19, 2012
First Submitted That Met QC Criteria
August 21, 2012
First Posted (Estimate)
August 24, 2012
Study Record Updates
Last Update Posted (Estimate)
June 19, 2013
Last Update Submitted That Met QC Criteria
June 18, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MFL University
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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