Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency
Public ClinicalTrials.gov record NCT00243542. 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
ACZ ACN 01. A Phase 4, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Cross-Over Study to Further Evaluate the Risk of Hematological Adverse Events in G6PD-Deficient Subjects With Acne Vulgaris Treated With ACZONE™ (Dapsone) Gel, 5%.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to gather more information about the safety of ACZONE Gel, 5% in treating subjects with acne who have certain blood disorders. ACZONE Gel, 5% is a prescription skin use (topical) medicine used to help treat acne in people 12 years and older. ACZONE Gel, 5% has been studied in approximately 4000 people and was shown to reduce the number of pimples and improve acne. The active drug ingredient in ACZONE Gel, 5% is dapsone. People with blood disorders called "G6PD deficiency", "methemoglobin reductase deficiency", and "hemoglobin M" have a higher chance of side effects with dapsone. G6PD is short for "glucose-6-phosphate dehydrogenase". It is an enzyme found in red blood cells, which carry oxygen to all parts of the body. G6PD helps the red blood cells to function normally. Some people have less G6PD in their red blood cells than the average person. This is called G6PD deficiency. Two treatments - ACZONE Gel, 5% and placebo - will be studied for comparison.
Study identification
- NCT ID
- NCT00243542
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 64 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 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
- Nov 2005 (Type not available)
- Primary completion
- Oct 2006 (Actual)
- Completion
- Oct 2006 (Actual)
- Last update posted
- May 30, 2011
2005 – 2006
United States locations
- U.S. sites
- 29
- U.S. states
- 18
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Radiant Research, Inc. | Birmingham | Alabama | 35209 | — |
| Therapeutics Clinical Research | San Diego | California | 92123 | — |
| Department of Dermatology, University of California, San Francisco | San Francisco | California | 94115 | — |
| Dermatology Associates, PC at the Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Howard University Hospital Department of Dermatology | Washington D.C. | District of Columbia | 20060 | — |
| FXM Research | Miami | Florida | 33175 | — |
| University Clinical Research, Inc | Pembroke Pines | Florida | 33024 | — |
| MedaPhase, Inc. | Newnan | Georgia | 30263 | — |
| Boston Clinical Trials | Boston | Massachusetts | 02135 | — |
| Henry Ford Medical Center - New Center One | Detroit | Michigan | 48202 | — |
| Washington University Dermatology Clinical Trials Unit | St Louis | Missouri | 63110 | — |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | — |
| Department of Dermatology SUNY Downstate Medical Center | Brooklyn | New York | 11203 | — |
| Columbia University Medical Center Department of Dermatology | New York | New York | 10032 | — |
| Metrolina Medical Research | Charlotte | North Carolina | 28209 | — |
| Universtiy Dermatology Consultants, Inc. | Cincinnati | Ohio | 45219 | — |
| Paddington Testing Clinic | Philadelphia | Pennsylvania | 19103 | — |
| Society Hill Dermatology | Philadelphia | Pennsylvania | 19107-6129 | — |
| Okatie Research Center, LLC | Beaufort | South Carolina | 29907' | — |
| Dermatology Associates of Knoxville | Knoxville | Tennessee | 37917 | — |
| Dermatology Research Associates | Nashville | Tennessee | 37203 | — |
| DermResearch, Inc. | Austin | Texas | 78759 | — |
| DiscoveResearch, Inc. | Beaumont | Texas | 77701 | — |
| J&S Studies, Inc. | Bryan | Texas | 77802 | — |
| Research Across America | Dallas | Texas | 75234 | — |
| Suzanne Bruce and Associates, PA | Houston | Texas | 77056 | — |
| The Education and Research Foundation, Inc. | Lynchburg | Virginia | 24501 | — |
| Virginia Clinical Research | Norfolk | Virginia | 23507 | — |
| Advanced Healthcare, SC | Milwaukee | Wisconsin | 53209 | — |
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 NCT00243542, 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 30, 2011 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00243542 live on ClinicalTrials.gov.