Latisse (Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Kenneth Beer, Beer, Kenneth R., M.D., PA
ClinicalTrials.gov Identifier:
NCT01387906
First received: July 1, 2011
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

The primary purpose of this study is to assess efficacy and safety of Latisse (bimatoprost .03% ophthalmic solution) applied to the lateral and medial eyebrows. The primary outcome is a increase in overall eyebrow prominence as measured by at least a 1-grade increase on the Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will be day 270 period.


Condition Intervention Phase
Hypotrichosis
Drug: topical bimatoprost
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Latisse(Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo

Resource links provided by NLM:


Further study details as provided by Beer, Kenneth R., M.D., PA:

Primary Outcome Measures:
  • Efficacy of Latisse applied to the lateral and medial eyebrow [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Increase in overall eyebrow prominence as measured by at least a 1-grade increase on the Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will be day 270 period.


Enrollment: 20
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topical bimatoprost for eyebrows
Topical bimatoprost will be applied to areas of the eyebrow that have diminished eyebrows (hypotrichosis).
Drug: topical bimatoprost
topical bimatoprost will be applied one drop to each eyebrow each night.
Other Name: bimatoprost, Latisse, eyebrows

  Eligibility

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

Inclusion Criteria:

  • Outpatient, female/male subjects of any race, 18-75 years of age.
  • Subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study
  • Patients with hypotrichosis (thinning) of the eyebrows with a GEyA score of 1 or 2.
  • Patient agrees to abstain from any treatment to the eyebrows including: waxing, plucking, threading, laser hair removal, and/or bleaching (excluding the glabella region).
  • Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms.
  • Written informed consent and written authorization for use or release of health and research information obtained.
  • Willing to complete all required study visits, procedures, and evaluations including photography.

Exclusion Criteria:

  • Subjects who are pregnant (positive urine pregnancy test), planning to become pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
  • Patients with any uncontrolled systemic disease
  • Patient with any known disease or abnormality of the eyebrows including eczema and seborrheic dermatitis
  • Patients with known or suspected trichotillomania disorder
  • Patients with a history of glaucoma and/or increased ocular pressure
  • Patients who are currently using an IOP-lowering prostaglandin analog (including Lumigan)
  • Patients with a known hypersensitivity to bimatoprost or any other ingredient in Latisse
  • Previous cosmetic surgery to the upper face (e.g., periorbital surgery, brow lift, eyelid or eyebrow surgery, etc.).
  • Patients with permanent eye and/or eyebrow make-up
  • Any eyebrow tint or dye applications within 2 months prior to study entry
  • Any planned facial cosmetic procedure that would interfere with the evaluation of the eyebrows
  • Participation in another investigational drug or device study within the last 30 days
  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: NCT01387906

Locations
United States, Florida
Kenneth R. Beer, M.D. ,PA
West Palm Beach, Florida, United States, 33401
Sponsors and Collaborators
Kenneth Beer
Allergan
Investigators
Principal Investigator: Kenneth Beer, M.D. Beer, Kenneth R., M.D., PA
  More Information

Additional Information:
Publications:
Responsible Party: Kenneth Beer, Investigator, Beer, Kenneth R., M.D., PA
ClinicalTrials.gov Identifier: NCT01387906     History of Changes
Other Study ID Numbers: Latisse2010
Study First Received: July 1, 2011
Last Updated: June 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Beer, Kenneth R., M.D., PA:
mild
moderate

Additional relevant MeSH terms:
Hypotrichosis
Hair Diseases
Skin Diseases
Bimatoprost
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014