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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 is a Phase 4 study that has completed, run by Allergan. The registered enrollment target is 64 participants.

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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

FieldValue
Enrollment Target 64 participants
Start Date 2005-11
Est. Completion 2006-10
Phase Phase 4

Sponsor

Allergan

314 total trials

What the Registry Record Tells You About NCT00243542

The ClinicalTrials.gov registry entry for NCT00243542 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.

NCT00243542 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.