Bimatoprost for the Treatment of Eyebrow Hypotrichosis

NCT ID: NCT01765764

Last Updated: 2019-04-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

357 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-13

Study Completion Date

2014-02-11

Brief Summary

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This study will evaluate the safety and efficacy of bimatoprost solution compared with vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).

Detailed Description

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Conditions

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Eyebrow Hypotrichosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bimatoprost Solution BID

Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.

Group Type EXPERIMENTAL

bimatoprost solution

Intervention Type DRUG

Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.

Bimatoprost Solution QD

Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.

Group Type EXPERIMENTAL

bimatoprost solution

Intervention Type DRUG

Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.

Vehicle to bimatoprost solution

Intervention Type DRUG

Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.

Vehicle to Bimatoprost Solution BID

Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.

Group Type PLACEBO_COMPARATOR

Vehicle to bimatoprost solution

Intervention Type DRUG

Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.

Interventions

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bimatoprost solution

Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.

Intervention Type DRUG

Vehicle to bimatoprost solution

Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

-Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth).

Exclusion Criteria

* Patients with disease, infection, or abnormality of the eyebrow area
* Patients with permanent eyebrow loss due to over-grooming
Minimum Eligible Age

18 Years

Eligible Sex

ALL

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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Houston, Texas, United States

Site Status

Vancouver, British Columbia, Canada

Site Status

Countries

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United States Canada

References

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Carruthers J, Beer K, Carruthers A, Coleman WP 3rd, Draelos ZD, Jones D, Goldman MP, Pucci ML, VanDenburgh A, Weng E, Whitcup SM. Bimatoprost 0.03% for the Treatment of Eyebrow Hypotrichosis. Dermatol Surg. 2016 May;42(5):608-17. doi: 10.1097/DSS.0000000000000755.

Reference Type BACKGROUND
PMID: 27124878 (View on PubMed)

Other Identifiers

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192024-043

Identifier Type: -

Identifier Source: org_study_id

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