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

NCT00031096 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 879

Last updated 2023-06-09

No results posted yet for this 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.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Azelaic Acid Gel 15% (Finacea, BAY39-6251)

Azelaic Acid 15% gel (SH H 655 BA) applied topically two times per day.

DRUG

Vehicle gel (SH H 655 PBA)

Vehicle gel (SH H 655 PBA) applied topically two times per day.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2002-07-31
Completion
2002-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00031096 on ClinicalTrials.gov