Study of Bimatoprost Gel on Eyelash Growth

NCT ID: NCT01200251

Last Updated: 2014-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-12-31

Brief Summary

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A internally controlled, single-blinded, randomized controlled trial to investigate the use of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and IRB approval have been obtained.

Detailed Description

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Conditions

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Madarosis Hypotrichosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bimatoprost treated eyelid

one eyelid of the patient was randomized to the treatment arm and given the gel to use

Group Type EXPERIMENTAL

Bimatoprost eyelash gel

Intervention Type DRUG

Bimatoprost 0.03% solution was compounded into a gel - patients used on eyelash margin once daily placing gel with a fingertip or Q-tip for 6 months

control arm - no gel

the other fellow eyelid of the patient did not receive any treatment until month 4 and the patient crossed over to treating both eyelids

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bimatoprost eyelash gel

Bimatoprost 0.03% solution was compounded into a gel - patients used on eyelash margin once daily placing gel with a fingertip or Q-tip for 6 months

Intervention Type DRUG

Other Intervention Names

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lumigan

Eligibility Criteria

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Inclusion Criteria

* 18-80 YO females
* madarosis or hypotrichosis (loss of eyelashes) due to chemotherapy used to treat breast cancer
* only breast cancer patients

Exclusion Criteria

* inability to follow up, apply gel
* active eye/eyelid infection or inflammatory process
* cancer not related to breast cancer, healthy patients
* males
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Tosti A, Pazzaglia M, Voudouris S, Tosti G. Hypertrichosis of the eyelashes caused by bimatoprost. J Am Acad Dermatol. 2004 Nov;51(5 Suppl):S149-50. doi: 10.1016/j.jaad.2004.05.002.

Reference Type RESULT
PMID: 15577756 (View on PubMed)

Other Identifiers

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71320

Identifier Type: REGISTRY

Identifier Source: secondary_id

9459

Identifier Type: -

Identifier Source: org_study_id

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