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Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia

NCT ID: NCT01189279

Last Updated: 2013-08-30

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

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-02-28

Brief Summary

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This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Part 2 will begin after Part 1 has completed.

Detailed Description

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Conditions

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Alopecia Alopecia, Androgenetic Baldness

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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Part 1: bimatoprost Formulation A

bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.

Group Type EXPERIMENTAL

bimatoprost Formulation A

Intervention Type DRUG

bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.

Part 1: bimatoprost Formulation B

bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.

Group Type EXPERIMENTAL

bimatoprost Formulation B

Intervention Type DRUG

bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.

Part 2: bimatoprost Formulation C

bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.

Group Type EXPERIMENTAL

bimatoprost Formulation C

Intervention Type DRUG

bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.

Interventions

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bimatoprost Formulation A

bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.

Intervention Type DRUG

bimatoprost Formulation B

bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.

Intervention Type DRUG

bimatoprost Formulation C

bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males with moderate male-pattern baldness (androgenic alopecia)
* Females with moderate female pattern hair loss
* Non-smoker or smoker with at least 30 days abstinence from smoking/using nicotine-containing products

Exclusion Criteria

* Any dermatological condition of the scalp other than androgenic alopecia (males) or female pattern hair loss (females)
* Use of bimatoprost or other prostaglandin analogs within 3 months
* Prior use of scalp hair growth treatment (eg, finasteride, minoxidil) within 6 months
* Any prior hair growth procedures (eg, hair transplant or laser)
* Blood donation or equivalent blood loss within 90 days
* History of alcohol or drug addiction
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 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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Tempe, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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192024-053

Identifier Type: -

Identifier Source: org_study_id