Phase 3 N=962 Randomized Single-blind Treatment

CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study

Papulopustular Rosacea

Bottom Line

View on ClinicalTrials.gov: NCT01493947 ↗

Enrolled (actual)

962

Serious AEs

2.0%

Results posted

Oct 2015

Primary outcome: Primary: Percent Change in Inflammatory Lesions From Baseline to Week 16 — -83; -73.7 percentage of change

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ivermectin 1% cream (Drug); Metronidazole 0.75% cream (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Inflammatory Lesions From Baseline to Week 16	-83; -73.7	—

Summary

Study objectives: * To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment. * And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period by assessing, the time of first relapse, the relapse rate, and the number of days free of treatment

Eligibility Criteria

Inclusion Criteria

Subjects with papulopustular rosacea scored 3 (moderate) or 4 (severe) according to the Investigator Global Assessment (IGA),
Subjects with at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.

Exclusion Criteria

Subjects with particular forms of rosacea (rosacea conglobate, rosacea fulminant, 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 pilar, or seborrheic dermatitis and acne,
Subjects with rosacea with more than two nodules on the face.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01493947). 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.