- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01325350
Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss
March 3, 2014 updated by: Allergan
This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern hair loss.
All treatments will be provided in a double-blinded fashion except for minoxidil 2% solution which will be provided open-label.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
306
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany
-
-
-
-
Oregon
-
Portland, Oregon, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 57 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Mild to moderate female pattern hair loss with ongoing hair loss for at least 1 year
- Willingness to have micro-dot-tattoo applied to scalp
- Willingness to maintain same hair style, length and hair color during study
Exclusion Criteria:
- Drug or alcohol abuse within 12 months
- HIV positive
- Received hair transplants or had scalp reductions
- Use of hair weaves, hair extensions or wigs within 3 months
- Oral or topical minoxidil treatment within 6 months
- Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: bimatoprost Formulation A
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Experimental: bimatoprost Formulation B
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Experimental: bimatoprost Formulation C
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Placebo Comparator: bimatoprost vehicle solution
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Active Comparator: minoxidil 2% solution
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
|
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Time Frame: Baseline, Month 6
|
The SSA score measured scalp hair growth.
Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased.
The percentage of participants in each response category is presented.
|
Baseline, Month 6
|
Change From Baseline in Target Area Hair Count (TAHC)
Time Frame: Baseline, Month 6
|
TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2).
A positive change from Baseline indicated improvement (increase in the number of terminal hairs).
A negative change from Baseline indicated worsening (decrease in the number of terminal hairs).
|
Baseline, Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Time Frame: Baseline, Month 6
|
The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased.
The percentage of participants in each response category is presented.
|
Baseline, Month 6
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Time Frame: Baseline, Month 6
|
At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased.
The percentage of participants in each response category is presented.
|
Baseline, Month 6
|
Change From Baseline in Target Area Hair Width (TAHW)
Time Frame: Baseline, Month 6
|
Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2).
The diameters of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and reported together.
A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs).
A negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).
|
Baseline, Month 6
|
Change From Baseline in Target Area Hair Darkness (TAHD)
Time Frame: Baseline, Month 6
|
Digital imaging analysis was used to measure TAHD.
The darkness of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units.
A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).
|
Baseline, Month 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
March 28, 2011
First Submitted That Met QC Criteria
March 28, 2011
First Posted (Estimate)
March 29, 2011
Study Record Updates
Last Update Posted (Estimate)
April 9, 2014
Last Update Submitted That Met QC Criteria
March 3, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 192024-058
- 2011-000380-27 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alopecia
-
Siriraj HospitalCompletedRecalcitrant Alopecia Totalis | Recalcitrant Alopecia UniversalisThailand
-
Yale UniversityCompletedFibrosing Alopecia | Frontal Fibrosing Alopecia | Central Centrifugal Cicatricial AlopeciaUnited States
-
Aclaris Therapeutics, Inc.CompletedAlopecia Totalis (AT) | Alopecia Universalis (AU)United States
-
Yale UniversityCompletedAlopecia Areata (AA) | Alopecia Totalis (AT) | Alopecia Universalis (AU)United States
-
M.D. Anderson Cancer CenterNational Alopecia Areata FoundationActive, not recruitingAlopecia Areata | Alopecia Totalis | Alopecia Universalis | Autoimmune Hair Loss | Alopecia PartialisUnited States
-
Wake Forest University Health SciencesThe Skin of Color SocietyRecruitingCentral Centrifugal Cicatricial Alopecia (CCCA)United States
-
Erasmus Medical CenterRecruitingAutoimmune Diseases | Alopecia | Alopecia Areata | Hair Diseases | Alopecia Totalis | Alopecia Universalis | Hair Loss | Alopecia DrugsNetherlands
-
King Saud UniversitySaudi Society of Dermatology and Dermatologic surgeryCompletedAlopecia Totalis | Alopecia Universalis | Ophiasic AlopeciaSaudi Arabia
-
EquilliumWithdrawnAlopecia Areata | Alopecia Totalis | Alopecia Universalis
-
Lindsey BordoneWithdrawnAlopecia Areata | Alopecia Totalis | Alopecia Universalis
Clinical Trials on bimatoprost Formulation A
-
AllerganCompletedAlopecia | Alopecia, Androgenetic | BaldnessUnited States
-
AllerganCompletedAndrogenetic AlopeciaUnited States
-
AllerganCompletedIdiopathic Eyelash HypotrichosisRussian Federation, Sweden, United States, United Kingdom
-
AllerganCompletedAlopecia | Alopecia, Androgenetic | BaldnessUnited States, Germany
-
AllerganCompletedOcular Hypertension | GlaucomaUnited States
-
AllerganCompletedOcular Hypertension | Primary Open-Angle GlaucomaUnited States
-
AllerganCompletedOcular Hypertension | GlaucomaUnited States
-
AllerganTerminatedGlaucomaUnited Kingdom, Taiwan, Korea, Republic of, United States, Italy, Philippines, France
-
ViiV HealthcareGlaxoSmithKlineNot yet recruiting
-
GlaxoSmithKlineCompletedMultiple SclerosisPoland, Germany, Czechia