Safety and Efficacy of Bimatoprost 0.03% Solution for the Treatment of Thinning Eyebrows

January 12, 2015 updated by: ATS Clinical Research

Safety and Efficacy of Bimatoprost 0.03% Solution for the Treatment of Eyebrow Hypotrichosis: A Phase 4 Investigator Initiated Study

This is a study researching the safety and efficacy of Bimatoprost 0.03% soultion versus placebo applied to the eyebrow for the treatment of thinning eyebrows. This is a 36 week study where Bimatoprost 0.03% solution/placebo will be applied once daily to the subjects eyebrow for duration of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A parallel, placebo-controlled, single-center, prospective, randomized, double blind, pilot trial to demonstrate bimatoprost 0.03% efficacy in eyebrow hypotrichosis in otherwise healthy individuals with thinning eyebrows. Bimatoprost 0.03% or placebo will be applied to the eyebrow margin once daily for 36 weeks. Adverse events will be assessed, and subjects will complete outcomes questionnaires at study visits. Eyebrow growth and darkening will be scored by the investigator and photography will be taken at each study visit.

Eyebrows are generally composed of three types of hairs: fine vellus hairs are the smallest, with the second type slightly larger, lightly pigmented hairs. The supercilia are the large terminal hairs which are the most visible and are primarily responsible for color and shape of the brow. Eyelashes are composed of terminal hairs, and it has been well demonstrated that bimatoprost application on these hairs will render them longer, thicker and darker (Allergan Protocol 192024-032). It has also been demonstrated that bimatoprost will darken vellus hair, making them more visible. It may be that administering bimatoprost to the eyebrows will cause the terminal hair to become longer, thicker and darker, and make the vellus and lightly pigmented hairs become more noticeable, thus increasing the intensity and fullness of the entire brow.

Multiple studies have been conducted to assess the safety and efficacy of the application of bimatoprost solution to the eyelid for growth of natural eyelashes (Yoelin S, et al, 2010). In 2 active-controlled phase 3 studies for LUMIGAN®, eyelash growth was reported as an adverse event after 3 months of treatment of subjects receiving bimatoprost once daily (Allergan Studies 192024-008 and 192024-009). The application of bimatoprost solution to the eyelid has proven to be effective in enhancing eyelash growth in women when applied daily for 12 weeks (Cohen JL, 2010).

This drug effect has been formally acknowledged in the LUMIGAN® package insert (Appendix 5.2) further supporting the bimatoprost's effect on eyelash growth. The package insert indicates that LUMIGAN® may gradually change eyelashes with regard to increased length, thickness, pigmentation, and number of eyelashes. Since its US approval in 2001, several adverse events of "growth of eyelashes" have been reported in conjunction with the use of LUMIGAN®.

Subjects will be randomized to Track A, active study drug, bimatoprost 0.03% solution, or to Track B, placebo. Each track will apply the same dose, 1 drop per eyebrow once daily, to determine the safety and efficacy of bimatoprost 0.03% solution versus placebo.

Study Type

Interventional

Enrollment (Actual)

33

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

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • AVA MD

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Females and males, ages 18-75 years with brows that are naturally thinning with a score of 1 (very thin) or 2 (thin) at baseline as determined by the Investigator Global Eyebrow Assessment (IGEA).
  • Subjects who agree to forgo any additional treatment to the brows, such as waxing, plucking, threading and/or tinting for the duration of the study.
  • Desires to participate in a research study

Exclusion Criteria:

  • Any uncontrolled systemic disease.
  • Any known diseases or abnormalities to the eyelid or eyebrow.
  • Known allergies or reactions to bimatoprost or placebo ingredients.
  • Pregnancy.
  • Subjects that have thinning brows as a result of over plucking, trichotillomania, chemotherapy or any other condition or treatment that causes hair loss.
  • Subjects who have used any over the counter or prescription eyebrow growth product 3 months prior to baseline.
  • Subjects with tattooed eyebrows and/or any permanent or semi-permanent tint or dye within 3 months prior to baseline.
  • Subjects with a score of 3 or 4 on the eyebrow scale.
  • Current enrollment in an investigational drug or device study or participation in such a study 30 days prior to baseline.
  • Subjects using prostaglandin analogs for the treatment of high intraocular pressure.
  • Aphakic subjects and/or pseudophakic subjects with a torn posterior lens capsule.
  • Subjects with known risk factors for macular edema.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Track A
Those on active study medication
Drug: Track A
Bimatoprost 0.03% solution applied to eyebrow
Other Names:
  • Active study drug
  • Bimatoprost 0.03% solution
PLACEBO_COMPARATOR: Track B
Those on placebo.
Drug: Track B
Refresh Tears applied to eyebrows
Other Names:
  • Placebo control group
  • Refresh Tears

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One grade improvement at week 16, 24 and 36 as based on the IGEA
Time Frame: Week 16, 24 and 36
Target area of both left and right eyebrow will be examined for a one grade improvement based on the Investigator Global Eyebrow Assessment (IGEA) (section 17 of protocol) at baseline, week 16, 24 and 36 for Track A and Track B subjects. Target area is delineated by the mid-pupillary line to the lateral canthus.
Week 16, 24 and 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade improvement based on IEA4 at week 16, 24 and 36
Time Frame: Week 16, 24 and 36
Intensity (defined as thickness, darkness and hair quantity) of the target area of both left and right eyebrow based on the Investigator Eyebrow Assessment 4 Point Brow Scale at baseline, week 16, 24 and 36 for Track A and Track B subjects. Subject satisfaction with their brows (PRO measure) at week 36 for Track A Track B. Frequency and severity of adverse events.
Week 16, 24 and 36

Collaborators and Investigators

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

Sponsor

ATS Clinical Research

Collaborators

Allergan

Investigators

  • Principal Investigator: Ava Shamban, MD, ATS

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

May 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

June 28, 2013

First Submitted That Met QC Criteria

July 2, 2013

First Posted (ESTIMATE)

July 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATSBROW-001

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.

Clinical Trials on Hypotrichosis

Clinical Trials on Track A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe