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Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss

NCT ID: NCT01325350

Last Updated: 2014-04-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Alopecia Baldness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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bimatoprost Formulation A

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

Group Type EXPERIMENTAL

bimatoprost Formulation A

Intervention Type DRUG

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

bimatoprost Formulation B

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

Group Type EXPERIMENTAL

bimatoprost Formulation B

Intervention Type DRUG

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

bimatoprost Formulation C

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

Group Type EXPERIMENTAL

bimatoprost Formulation C

Intervention Type DRUG

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

bimatoprost vehicle solution

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

Group Type PLACEBO_COMPARATOR

bimatoprost vehicle solution

Intervention Type DRUG

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

minoxidil 2% solution

Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.

Group Type ACTIVE_COMPARATOR

minoxidil 2% solution

Intervention Type DRUG

Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.

Interventions

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bimatoprost Formulation A

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

Intervention Type DRUG

bimatoprost Formulation B

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

Intervention Type DRUG

bimatoprost Formulation C

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

Intervention Type DRUG

bimatoprost vehicle solution

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

Intervention Type DRUG

minoxidil 2% solution

Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.

Intervention Type DRUG

Other Intervention Names

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Rogaine® Regaine®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Portland, Oregon, United States

Site Status

Berlin, , Germany

Site Status

Countries

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United States Germany

Other Identifiers

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2011-000380-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

192024-058

Identifier Type: -

Identifier Source: org_study_id

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