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NCT00243542 · ClinicalTrials.gov registry record · Phase 4
Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency
A Phase 4 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 4
- Development phase
- 64
- Enrollment target
NCT00243542: Completed Phase 4 study, sponsored by Allergan.
NCT00243542 is a Phase 4 study that has completed, run by Allergan. The registered enrollment target is 64 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00243542, a Phase 4 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 64 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Vehicle
- DRUG ACZONE Gel, 5%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2005-11 |
| Est. Completion | 2006-10 |
| Phase | Phase 4 |
What the finished NCT00243542 record still lists
NCT00243542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT00243542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00243542 about?
NCT00243542 is a clinical study titled "Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency". 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 stud...
What is the current status of trial NCT00243542?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 64 participants. The study started on 2005-11. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00243542?
The interventions under investigation include: Vehicle (DRUG), ACZONE Gel, 5% (DRUG).
Who is sponsoring clinical trial NCT00243542?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00243542's enrollment target sits among peer trials
64 1098th of 2000 higher than 895 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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