Bimatoprost in the Treatment of Eyelash Hypotrichosis

NCT ID: NCT01698554

Last Updated: 2015-02-10

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

464 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-03-31

Brief Summary

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This study will evaluate the safety and efficacy of bimatoprost solution formulation A compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash hypotrichosis (inadequate eyelashes).

Detailed Description

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Conditions

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Idiopathic Eyelash 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 formulation A solution

Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Group Type EXPERIMENTAL

bimatoprost formulation A solution

Intervention Type DRUG

Bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

bimatoprost solution 0.03 %

Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Group Type ACTIVE_COMPARATOR

bimatoprost solution 0.03 %

Intervention Type DRUG

Bimatoprost solution 0.03 % (LATISSE®) applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

vehicle of bimatoprost formulation A solution

Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Group Type PLACEBO_COMPARATOR

vehicle of bimatoprost formulation A solution

Intervention Type DRUG

Vehicle of bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

vehicle of bimatoprost solution 0.03 %

Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Group Type PLACEBO_COMPARATOR

vehicle of bimatoprost solution 0.03 %

Intervention Type DRUG

Vehicle of bimatoprost solution 0.03 % applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Interventions

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bimatoprost formulation A solution

Bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Intervention Type DRUG

bimatoprost solution 0.03 %

Bimatoprost solution 0.03 % (LATISSE®) applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Intervention Type DRUG

vehicle of bimatoprost formulation A solution

Vehicle of bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Intervention Type DRUG

vehicle of bimatoprost solution 0.03 %

Vehicle of bimatoprost solution 0.03 % applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Intervention Type DRUG

Other Intervention Names

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LATISSE®

Eligibility Criteria

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Inclusion Criteria

-Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).

Exclusion Criteria

* Damage to eyelid area (scarring) that may prevent growth of eyelashes
* Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye)
* Eye or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to screening
* Current eyelash implants of any kind
* Eyelash tint or dye application within 2 months of baseline
* Eyelash extensions application within 3 months of baseline
* Use of eyelash growth products within 6 months of baseline
* Treatments that may affect hair growth (minoxidil, cancer chemotherapeutic agents, etc) within 6 months prior to baseline.
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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Newport Beach, California, United States

Site Status

Saint Petersburg, , Russia

Site Status

Stockholm, , Sweden

Site Status

Norfolk, England, United Kingdom

Site Status

Countries

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United States Russia Sweden United Kingdom

Other Identifiers

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2012-003007-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

192024-046

Identifier Type: -

Identifier Source: org_study_id

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