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Local Pharmacokinetics and Tolerability of Bimatoprost Applied to the Scalp of Male Patients With Androgenetic Alopecia

NCT ID: NCT02848300

Last Updated: 2016-10-26

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

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-10-31

Brief Summary

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This study will evaluate the skin pharmacokinetics and tolerability of bimatoprost Formulation A and Formulation B following 14 days of once daily topical administration in male participants with androgenetic alopecia (AGA).

Detailed Description

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Single-center, multiple-dose study evaluting the local pharmacokinetics and tolerability of bimatoprost following 14 days of once daily topical administration of bimatoprost Formulation A and Formulation B (both containing 1% bimatoprost) to the scalp of male patients With androgenetic alopecia

Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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All Participants

Bimatoprost 1% Formulation A solution applied to the left side of the scalp and trunk area and Bimatoprost 1% Formulation B solution applied to the right side of the scalp and trunk area once daily for 14 days.

Group Type EXPERIMENTAL

Bimatoprost 1% Formulation A

Intervention Type DRUG

Bimatoprost 1% Formulation A solution applied to the scalp and trunk once daily for 14 days.

Bimatoprost 1% Formulation B

Intervention Type DRUG

Bimatoprost 1% Formulation B solution applied to the scalp and trunk once daily for 14 days.

Interventions

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Bimatoprost 1% Formulation A

Bimatoprost 1% Formulation A solution applied to the scalp and trunk once daily for 14 days.

Intervention Type DRUG

Bimatoprost 1% Formulation B

Bimatoprost 1% Formulation B solution applied to the scalp and trunk once daily for 14 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

-Patients with mild to moderate Androgenetic Alopecia of the vertex area of the scalp.

Exclusion Criteria

* Patients with uncontrolled systemic disease
* History of significant cardiovascular disease
* Scarring disease, infection, or abnormality of the scalp or hair shaft or systemic disease that could cause temporary hair loss (eg, seborrheic dermatitis, psoriatic dermatitis, alopecia areata, cicatricial alopecia, uncontrolled hyperthyroidism/hypothyroidism, tinea infections, and genetic disorders)
* Patients who have received hair transplants or have had scalp reductions
* Abnormal bone biomarker laboratory results.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

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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Danielle McGeeney

Role: STUDY_DIRECTOR

Allergan

Locations

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DermResearch, LLC

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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1666-101-012

Identifier Type: -

Identifier Source: org_study_id