Expired Study
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West Palm Beach, Florida 33401


Purpose:

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.


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


Study is Available At:


Original ID:

Latisse2010


NCT ID:

NCT01387906


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Beer, Kenneth R., M.D., PA


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kenneth Beer, M.D.
Principal Investigator
Beer, Kenneth R., M.D., PA

Study Dates

Start Date:March 2011
Completion Date:June 2012
Completion Type:Actual
Primary Completion Date:March 2012
Primary Completion Type:Actual
Verification Date:June 2012
Last Changed Date:June 14, 2012
First Received Date:July 1, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Efficacy of Latisse applied to the lateral and medial eyebrow
Time Frame:10 months
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Drug
Name:topical bimatoprost
Description:topical bimatoprost will be applied one drop to each eyebrow each night.
Arm Name:Topical bimatoprost for eyebrows
Other Name:bimatoprost, Latisse, eyebrows

Study Arms

Study Arm Type:Experimental
Arm Name:Topical bimatoprost for eyebrows
Description:Topical bimatoprost will be applied to areas of the eyebrow that have diminished eyebrows (hypotrichosis).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Kenneth Beer
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Allergan

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:[No authors listed] Bimatoprost 0.03% solution (latisse) for eyelash enhancement. Med Lett Drugs Ther. 2009 Jun 1;51(1313):43-4. No abstract available.
PMID:19478690
Reference Type:Reference
Citation:Law SK. Bimatoprost in the treatment of eyelash hypotrichosis. Clin Ophthalmol. 2010 Apr 26;4:349-58.
PMID:20463804

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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