Latisse (Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
This study has been completed.
Information provided by (Responsible Party):
Kenneth Beer, Beer, Kenneth R., M.D., PA
First received: July 1, 2011
Last updated: June 14, 2012
Last verified: June 2012
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.
Drug: topical bimatoprost
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Latisse(Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2012 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387906
|Kenneth R. Beer, M.D. ,PA
|West Palm Beach, Florida, United States, 33401 |
||Kenneth Beer, M.D.
||Beer, Kenneth R., M.D., PA
||Kenneth Beer, Investigator, Beer, Kenneth R., M.D., PA
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 1, 2011
||June 14, 2012
||United States: Food and Drug Administration
Keywords provided by Beer, Kenneth R., M.D., PA:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Contraceptive Agents, Female
Reproductive Control Agents
Physiological Effects of Drugs