Latisse (Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01387906|
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : June 15, 2012
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Hypotrichosis||Drug: topical bimatoprost||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Latisse(Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||June 2012|
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
- Efficacy of Latisse applied to the lateral and medial eyebrow [ Time Frame: 10 months ]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.
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387906
|United States, Florida|
|Kenneth R. Beer, M.D. ,PA|
|West Palm Beach, Florida, United States, 33401|
|Principal Investigator:||Kenneth Beer, M.D.||Beer, Kenneth R., M.D., PA|
|Responsible Party:||Kenneth Beer, Investigator, Beer, Kenneth R., M.D., PA|
|Other Study ID Numbers:||
|First Posted:||July 6, 2011 Key Record Dates|
|Last Update Posted:||June 15, 2012|
|Last Verified:||June 2012|