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
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
|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 November 25, 2014
Contraceptive Agents, Female
Physiological Effects of Drugs
Reproductive Control Agents