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

NCT01891487 | Completed Phase 4

• 1 other identifier: ATSBROW-001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypotrichosis

Keywords

Eyebrow; Hypotrichosis; Thinning; Bimatoprost

Outcome Measures

Primary Outcomes (1)

• One grade improvement at week 16, 24 and 36 as based on the IGEA

  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 Outcomes (1)

• Grade improvement based on IEA4 at week 16, 24 and 36

  Week 16, 24 and 36

Study Arms (2)

Track A

ACTIVE COMPARATOR

Those on active study medication

Drug: Track A

Track B

PLACEBO COMPARATOR

Those on placebo.

Drug: Track B

Interventions

Track A DRUG

Bimatoprost 0.03% solution applied to eyebrow

Also known as: Active study drug, Bimatoprost 0.03% solution

Track A

Track B DRUG

Refresh Tears applied to eyebrows

Also known as: Placebo control group, Refresh Tears

Track B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ATS Clinical Research: lead
• Allergan: collaborator

Study Sites (1)

Ava MD

Santa Monica, California, 90404, United States

Location

Related Publications (5)

• Allergan Protocol 192024-032, June 2008 Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence.

  BACKGROUND

• Allergan Protocol 192024-008 A multicenter, double-masked, randomized, parallel, three-month study (with treatment extended to one year) of the safety and efficacy of ANG 192024 0.03% ophthalmic solution, administered once- daily or twice-daily compared with timolol 0.5% ophthalmic solution administered twice-daily, in subjects with glaucoma or ocular hypertension [12 month report].

  RESULT

• Allergan Protocol 192024-009 A multicenter, double-masked, randomized, parallel, three-month study (with treatment extended to one year) of the safety and efficacy of ANG 192024 0.03% ophthalmic solution administered once-daily or twice daily compare with timolol 0.5% ophthalmic solution administered twice-daily, in subjects with glaucoma or ocular hypertension [12 month report].

  RESULT

• Cohen JL. Enhancing the growth of natural eyelashes: the mechanism of bimatoprost-induced eyelash growth. Dermatol Surg. 2010 Sep;36(9):1361-71. doi: 10.1111/j.1524-4725.2010.01522.x.

  PMID: 20384750 RESULT

• Yoelin S, Walt JG, Earl M. Safety, effectiveness, and subjective experience with topical bimatoprost 0.03% for eyelash growth. Dermatol Surg. 2010 May;36(5):638-49. doi: 10.1111/j.1524-4725.2010.01519.x. Epub 2010 Apr 1.

  PMID: 20384751 RESULT

MeSH Terms

Conditions

Hypotrichosis

Interventions

Bimatoprost; Solutions

Condition Hierarchy (Ancestors)

Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Preparations

Study Officials

• Ava Shamban, MD

  ATS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 3, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2015
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

US (1)