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Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne

NCT ID: NCT01425320

Last Updated: 2012-11-19

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-06-30

Brief Summary

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This study will investigate the pharmacokinetics, safety and tolerability of dapsone and adapalene following topical administration of 2 formulations of dapsone/adapalene fixed combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects with acne vulgaris.

Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Fixed Combination dapsone/adapalene Formulation A Gel

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Group Type EXPERIMENTAL

Fixed Combination dapsone/adapalene Formulation A Gel

Intervention Type DRUG

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Fixed Combination dapsone/adapalene Formulation B Gel

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Group Type EXPERIMENTAL

Fixed Combination dapsone/adapalene Formulation B Gel

Intervention Type DRUG

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

dapsone 5% gel (ACZONE®)

Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.

Group Type ACTIVE_COMPARATOR

dapsone 5% gel

Intervention Type DRUG

Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.

adapalene 0.3% gel (Differin®)

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Group Type ACTIVE_COMPARATOR

adapalene 0.3% gel

Intervention Type DRUG

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Interventions

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Fixed Combination dapsone/adapalene Formulation A Gel

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Intervention Type DRUG

Fixed Combination dapsone/adapalene Formulation B Gel

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Intervention Type DRUG

dapsone 5% gel

Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.

Intervention Type DRUG

adapalene 0.3% gel

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Intervention Type DRUG

Other Intervention Names

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ACZONE® Differin®

Eligibility Criteria

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Inclusion Criteria

* Moderate acne on the face
* Willing to avoid swimming during the study
* Willing to avoid excessive sunlight and ultraviolet light (e.g., tanning beds)during the study
* Willing to avoid moisturizers, sunscreens, cosmetics, and chemical peels during the study

Exclusion Criteria

* Severe cystic acne
* Use of topical or oral retinoids within 4 weeks
* Use of isotretinoin within 3 months
* Use of dapsone or adapalene within 3 months
* Anticipated need to engage in activities/exercise that would cause profuse sweating
* Donated blood or equivalent blood loss within 90 days
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

Countries

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United States

Other Identifiers

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225678-003

Identifier Type: -

Identifier Source: org_study_id