An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris

NCT ID: NCT01785836

Last Updated: 2013-02-25

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WITHDRAWN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

2013-03-31

Study Completion Date

2013-10-31

Brief Summary

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This study will assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment.

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dapsone Formulation A

Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Group Type EXPERIMENTAL

Dapsone Formulation A

Intervention Type DRUG

Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Dapsone Formulation B

Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Group Type EXPERIMENTAL

Dapsone Formulation B

Intervention Type DRUG

Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Dapsone Formulation C

Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Group Type EXPERIMENTAL

Dapsone Formulation C

Intervention Type DRUG

Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Dapsone 5% Gel

Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Group Type ACTIVE_COMPARATOR

Dapsone 5% Gel

Intervention Type DRUG

Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Interventions

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Dapsone Formulation A

Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Intervention Type DRUG

Dapsone Formulation B

Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Intervention Type DRUG

Dapsone Formulation C

Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Intervention Type DRUG

Dapsone 5% Gel

Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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ACZONE®

Eligibility Criteria

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Inclusion Criteria

* Participation in Allergan study 225678-004

Exclusion Criteria

* Anticipates the need for surgery or hospitalization during the study
Minimum Eligible Age

12 Years

Maximum Eligible Age

35 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

Other Identifiers

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225678-005

Identifier Type: -

Identifier Source: org_study_id

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