Clinical trial NCT01387906: Latisse (Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
Official title: Latisse(Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypotrichosis
Keywords: mild
moderate
Lead sponsor: Beer, Kenneth R., M.D., PA
Sponsor class: INDIV
Collaborators: name: Allergan
First posted: 2011-07-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Efficacy of Latisse applied to the lateral and medial eyebrow
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Kenneth R. Beer, M.D. ,PA
state: Florida
Study officials:
affiliation: Beer, Kenneth R., M.D., PA
name: Kenneth Beer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Law SK. Bimatoprost in the treatment of eyelash hypotrichosis. Clin Ophthalmol. 2010 Apr 26;4:349-58. doi: 10.2147/opth.s6480.
citation: Bimatoprost 0.03% solution (latisse) for eyelash enhancement. Med Lett Drugs Ther. 2009 Jun 1;51(1313):43-4. No abstract available.