Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea

NCT01659853 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-08-25

Study results available
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Summary

The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea.

Conditions

  • Erythema
  • Rosacea

Interventions

DRUG

CD07805/47 gel 0.5%/CD07805/47 Vehicle

To maintain masking, CD07805/47 gel 0.5% will be administered along with CD07805/47 gel vehicle. During each treatment period (baseline to Day 15): CD07805/47 gel 0.5%, topical, once daily and CD07805/47 gel vehicle, topical, once daily

DRUG

azelaic acid gel 15%

During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Principal Investigators

  • Ronald W. Gottschalk, MD · Galderma R&D

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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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 NCT01659853 on ClinicalTrials.gov