A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.
Public ClinicalTrials.gov record NCT00249782. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Randomized, Partial-Blind, Parallel-Group, Active- and Vehicle-Controlled, Multicenter Study of the Safety and Efficacy of ACZONE™ (Dapsone) Gel, 5% in Subjects With Papulopustular Rosacea
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00249782
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2005
- Primary completion
- Apr 30, 2006
- Completion
- Apr 30, 2006
- Last update posted
- May 29, 2011
2005 – 2006
United States locations
- U.S. sites
- 26
- U.S. states
- 18
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Radiant Research | Birmingham | Alabama | 35209 | — |
| Radiant Research | Tucson | Arizona | 85710 | — |
| East Bay Dermatology Medical Group, Inc. | Fremont | California | 94538 | — |
| Therapeutics Clinical Research | San Diego | California | 92123 | — |
| Clincial Research Specialists, Inc. | Santa Monica | California | 90404 | — |
| Cherry Creek Research, Inc | Denver | Colorado | 80246 | — |
| The Savin Center, PC | New Haven | Connecticut | 06511 | — |
| Visions Clinical Research | Boynton Beach | Florida | 33437 | — |
| Tampa Bay Medical Research | Clearwater | Florida | 33761 | — |
| FXM Research | Miami | Florida | 33175 | — |
| University Clinical Research, Inc. | Pembroke Pines | Florida | 33024 | — |
| MedaPhase, Inc. | Newnan | Georgia | 30263 | — |
| Welborn Clinic | Evansville | Indiana | 478713 | — |
| Dermatology Clinical Trials Unit Washington University | St Louis | Missouri | 63110 | — |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | — |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | — |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | — |
| University Dermatology Consultants, Inc. | Cincinnati | Ohio | 45219 | — |
| Dermatology Research Associates Inc. | Cincinnati | Ohio | 45230 | — |
| Northwest Dermatology and Research Center | Portland | Oregon | 97210 | — |
| Oregon Medical Research Center | Portland | Oregon | 97223 | — |
| Paddington Testing Co., Inc. | Philadelphia | Pennsylvania | 19103 | — |
| Dermatology Research Association, Inc. | Nashville | Tennessee | 37203 | — |
| DermResearch, Inc. | Austin | Texas | 78759 | — |
| J&S Studies Inc. | Bryan | Texas | 77802 | — |
| Madison Skin & Research, Inc. | Madison | Wisconsin | 53719 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00249782, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 29, 2011 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00249782 live on ClinicalTrials.gov.