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

NCT01025635 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2020-03-31

Study results available
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Summary

This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.

Conditions

  • Papulopustular Rosacea

Interventions

DRUG

Azelaic acid foam 15%

Applied topically twice daily for 12 weeks

DRUG

Vehicle foam

Applied topically twice daily for 12 weeks

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-08-31
Completion
2010-08-31

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 NCT01025635 on ClinicalTrials.gov