Latisse (Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
This study has been completed.
Sponsor:
Kenneth Beer
Collaborator:
Allergan
Information provided by (Responsible Party):
Kenneth Beer, Beer, Kenneth R., M.D., PA
ClinicalTrials.gov Identifier:
NCT01387906
First received: July 1, 2011
Last updated: June 14, 2012
Last verified: June 2012
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypotrichosis |
Drug: topical bimatoprost |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Latisse(Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo |
Resource links provided by NLM:
MedlinePlus related topics:
Hair Loss
Drug Information available for:
Bimatoprost
U.S. FDA Resources
Further study details as provided by Beer, Kenneth R., M.D., PA:
Primary Outcome Measures:
- Efficacy of Latisse applied to the lateral and medial eyebrow [ Time Frame: 10 months ] [ Designated as safety issue: No ]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.
| Enrollment: | 20 |
| Study Start Date: | March 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387906
Locations
| United States, Florida | |
| Kenneth R. Beer, M.D. ,PA | |
| West Palm Beach, Florida, United States, 33401 | |
Sponsors and Collaborators
Kenneth Beer
Allergan
Investigators
| Principal Investigator: | Kenneth Beer, M.D. | Beer, Kenneth R., M.D., PA |
More Information
Additional Information:
Publications:
| Responsible Party: | Kenneth Beer, Investigator, Beer, Kenneth R., M.D., PA |
| ClinicalTrials.gov Identifier: | NCT01387906 History of Changes |
| Other Study ID Numbers: | Latisse2010 |
| Study First Received: | July 1, 2011 |
| Last Updated: | June 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Beer, Kenneth R., M.D., PA:
|
mild moderate |
Additional relevant MeSH terms:
|
Hypotrichosis Hair Diseases Skin Diseases Bimatoprost Cloprostenol Antihypertensive Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013