Clinical trialNCT00249782CompletedPhase 2Interventional

A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.

SponsorAllerganEnrollment400Rosacea

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for the treatment of rosacea. ACZONE™ gel, 5% is a topical (applied to the skin) medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12 years and older. The use of ACZONE™ for the treatment of rosacea is investigational. An investigational use is one that is not approved by the FDA. Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline and Week, 2, 4 and 12.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Steven Garrett, MS, DDS
QLT USA, Inc.
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

26 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Radiant Research
Birmingham, Alabama, United States
Radiant Research
Tucson, Arizona, United States
East Bay Dermatology Medical Group, Inc.
Fremont, California, United States
Therapeutics Clinical Research
San Diego, California, United States
Clincial Research Specialists, Inc.
Santa Monica, California, United States
Cherry Creek Research, Inc
Denver, Colorado, United States
the Savin Center, Pc
New Haven, Connecticut, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
Fxm Research
Miami, Florida, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
Medaphase, Inc.
Newnan, Georgia, United States
Welborn Clinic
Evansville, Indiana, United States
Dermatology Clinical Trials Unit Washington University
St Louis, Missouri, United States
Skin Specialists, Pc
Omaha, Nebraska, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Dermatology Consulting Services
High Point, North Carolina, United States
Dermatology Research Associates Inc.
Cincinnati, Ohio, United States
University Dermatology Consultants, Inc.
Cincinnati, Ohio, United States
Northwest Dermatology and Research Center
Portland, Oregon, United States
Oregon Medical Research Center
Portland, Oregon, United States
Paddington Testing Co., Inc.
Philadelphia, Pennsylvania, United States
Dermatology Research Association, Inc.
Nashville, Tennessee, United States
Dermresearch, Inc.
Austin, Texas, United States
J&s Studies Inc.
Bryan, Texas, United States
Madison Skin & Research, Inc.
Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ACZONE Gel, 5%, 1x/dayACZONE Gel, 5%, 1x/day + MetroGel, 1.0%, 1x/dayACZONE Gel, 5%, 2x/dayMetroGel®, 1.0% 1x/dayVehicle control, 2x/day

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Nov 2005
Primary completion: 31 May 2006
Completion: 31 May 2006
Last update posted: 30 May 2011
Registered enrollment: 400
Registry id: NCT00249782

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.