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

Launched by KENNETH BEER · Jul 5, 2011

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Gender

ALL

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