Minoxidil 1% for Eyebrow Enhancement

April 20, 2014 updated by: Chuchai TANGLERTSAMPAN, MD, Mae Fah Luang University Hospital

Minoxidil 1% for Eyebrow Enhancement: A Randomized , Double-blind , Placebo-controlled , Split-face Comparative Study

The purpose of the study is to compare efficacy and safety of minoxidil 1% 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

  • Thailand
      • Bangkok, Thailand
        • Mae Fah Luang University Hospital (Bangkok)

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female aged 18-60 years
  • hypotrichosis of eyebrows
  • healthy
  • informed consent obtained

Exclusion Criteria:

  • underlying diseases
  • alopecia areata or trichotillomania
  • thyroid diseases
  • pregnancy or breast feeding
  • previous eyebrow tattoo, trauma or accident.
  • history of eyebrow or hair medications in 6 months
  • history of minoxidil or its ingredient allergy
  • 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
Experimental: Minoxidil lotion 1%
Minoxidil lotion 1% is applied twice daily to one eyebrow.
Drug: Minoxidil lotion 1%
Minoxidil lotion 1% is applied twice daily to one eyebrow.
Placebo Comparator: Placebo
Placebo is applied twice daily to the other eyebrow.
Drug: Placebo
Other Names:
  • Placebo is applied twice daily on the other eyebrow.

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: baseline and 16 weeks
baseline and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mae Fah Luang University Hospital

Investigators

  • Principal Investigator: Chuchai Tanglertsampan, MD, Mae Fah Luang University Hospital (Bangkok)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

August 13, 2013

First Submitted That Met QC Criteria

August 15, 2013

First Posted (Estimate)

August 16, 2013

Study Record Updates

Last Update Posted (Estimate)

April 22, 2014

Last Update Submitted That Met QC Criteria

April 20, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REH-56059

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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