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

Phase 3

Completed

• Conditions: Papulopustular Rosacea
• Interventions: Drug: Metronidazole 0.75% cream; Drug: Ivermectin 1% cream

• Registration Number: NCT01493947
• Lead Sponsor: Galderma R&D

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-16
• Study Start: 2012-04
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2015-06-29
• Status Verified: 2015-09
• Results First Submitted QC: 2015-09-22
• Last Update Submitted: 2015-09-22
• Results First Posted: 2015-10-28
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 962

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metronidazole 0.75% cream	Metronidazole 0.75% cream	-
Ivermectin 1% cream	Ivermectin 1% cream	-

Primary Outcome Measures

Name	Time	Method
Percent Change in Inflammatory Lesions From Baseline to Week 16	Baseline and Week 16	Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period

Trial Locations

Locations (2)

Galderma Invetigational site; 🇨🇿 Olomouc, Czech Republic

Galderma Investigational Site; 🇬🇧 Nuneaton, United Kingdom