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NCT00031096 · ClinicalTrials.gov registry record · Phase 3

Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne

A Phase 3 study, sponsored by LEO Pharma.

Completed
Registry status
Phase 3
Development phase
879
Enrollment target

NCT00031096 is a Phase 3 study that has completed, run by LEO Pharma. The registered enrollment target is 879 participants.

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The verdict

NCT00031096, a Phase 3 study, has completed, sponsored by LEO Pharma.

COMPLETED
Registry status
Phase 3
Development phase
879 participants
Enrollment target

Study Summary

Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne. Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.

Interventions

  • DRUG Azelaic Acid Gel 15% (Finacea, BAY39-6251)
  • DRUG Vehicle gel (SH H 655 PBA)

Trial Details

FieldValue
Enrollment Target 879 participants
Start Date 2002-01
Est. Completion 2002-07
Phase Phase 3

Sponsor

LEO Pharma

65 total trials

What the Registry Record Tells You About NCT00031096

The ClinicalTrials.gov registry entry for NCT00031096 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 879 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LEO Pharma, which has 65 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Azelaic Acid Gel 15% (Finacea, BAY39-6251) is the first listed.

NCT00031096 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00031096 about?

NCT00031096 is a clinical study titled "Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne". Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne. Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.

What is the current status of trial NCT00031096?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 879 participants. The study started on 2002-01. Estimated completion is 2002-07.

What interventions are being tested in trial NCT00031096?

The interventions under investigation include: Azelaic Acid Gel 15% (Finacea, BAY39-6251) (DRUG), Vehicle gel (SH H 655 PBA) (DRUG).

Who is sponsoring clinical trial NCT00031096?

This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.

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

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.