Phase 3 N=683 Randomized Triple-blind Treatment

Phase 3 Papulopustular Rosacea Study

Papulopustular Rosacea (PPR)

Bottom Line

View on ClinicalTrials.gov: NCT01493687 ↗

Enrolled (actual)

683

Serious AEs

1.6%

Results posted

Jan 2015

Primary outcome: Primary: Success Rate — 38.4; 11.6 Percentage of participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: CD5024 (Drug); Azelaic acid 15% Gel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Success Rate	38.4; 11.6	<0.001 sig
PRIMARY Absolute Change in Inflammatory Lesion Count	-20.5; -12.0	<0.001 sig
SECONDARY Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)	-64.9; -41.6	<0.001 sig

Summary

The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.

Eligibility Criteria

Inclusion Criteria

The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe),
The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.

Exclusion Criteria

The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne,
The subject has rosacea with more than two nodules on the face.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01493687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.