MedDataX Logo

Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris

NCT ID: NCT00835198

Last Updated: 2011-10-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acne Vulgaris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Dapsone gel 5% and Tretinoin gel 0.025%

Group Type ACTIVE_COMPARATOR

Dapsone; Tretinoin

Intervention Type DRUG

Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks

2

Tretinoin gel 0.025%

Group Type ACTIVE_COMPARATOR

Tretinoin

Intervention Type DRUG

Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dapsone; Tretinoin

Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks

Intervention Type DRUG

Tretinoin

Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Aczone Gel 5%; Tretin-X Gel 0.025% Tretin-X Gel 0.025%

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Facial acne vulgaris characterized by the following:

* 30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions;
* Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm)
* Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study

Exclusion Criteria

* Non-compliance with washout period;
* History of clinically significant anemia or hemolysis;
* Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris;
* Allergy or sensitivity to any component of the test medications
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Strongsville, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MA-ACZ0801

Identifier Type: -

Identifier Source: org_study_id