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Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea

NCT01555463 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 961

Last updated 2023-06-09

Study results available
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Summary

The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.

Conditions

  • Papulopustular Rosacea

Interventions

DRUG

Azelaic acid foam, 15% (BAY39-6251)

Azelaic acid twice daily topical application

DRUG

Vehicle foam

twice daily topical application

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
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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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 NCT01555463 on ClinicalTrials.gov