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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by ATS Clinical Research
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
ATS Clinical Research
ClinicalTrials.gov Identifier:
NCT01891487
First received: June 28, 2013
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Hypotrichosis
Drug: Track A
Drug: Track B
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Bimatoprost 0.03% Solution for the Treatment of Eyebrow Hypotrichosis: A Phase 4 Investigator Initiated Study

Resource links provided by NLM:


Further study details as provided by ATS Clinical Research:

Primary Outcome Measures:
  • One grade improvement at week 16, 24 and 36 as based on the IGEA [ Time Frame: Week 16, 24 and 36 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Grade improvement based on IEA4 at week 16, 24 and 36 [ Time Frame: Week 16, 24 and 36 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891487

Contacts
Contact: Caitlin J Terrio, CRC 3108282282 caitlin@avamd.com
Contact: Erin Haight, RN, BSN, CRC 3108282282 research@avamd.com

Locations
United States, California
Ava MD Recruiting
Santa Monica, California, United States, 90404
Contact: Caitlin Terrio, CRC    310-828-2282    caitlin@avamd.com   
Contact: Erin Haight, RN, BSN, CRC    3108282282    research@avamd.com   
Principal Investigator: Ava T Shamban, MD         
Sponsors and Collaborators
ATS Clinical Research
Allergan
Investigators
Principal Investigator: Ava Shamban, MD ATS
  More Information

Publications:
Cohen JL., Enhancing the growth of natural eyelashes: the mechanism of bimatoprost-induced eyelash growth. Dermatol Surg. 2010 Sep;36(9):1361-71.

Responsible Party: ATS Clinical Research
ClinicalTrials.gov Identifier: NCT01891487     History of Changes
Other Study ID Numbers: ATSBROW-001
Study First Received: June 28, 2013
Last Updated: July 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ATS Clinical Research:
Eyebrow
Hypotrichosis
Thinning
Bimatoprost

Additional relevant MeSH terms:
Hypotrichosis
Hair Diseases
Skin Diseases
Bimatoprost
Pharmaceutical Solutions
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014