Status:
COMPLETED
CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study
Lead Sponsor:
Galderma R&D
Conditions:
Papulopustular Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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, f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
962 Patients enrolled
Trial Details
Trial ID
NCT01493947
Start Date
April 1 2012
End Date
December 1 2013
Last Update
October 28 2015
Active Locations (60)
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1
Galderma Investigational Site
Pleven, Bulgaria
2
Galderma Investigational Site
Plovdiv, Bulgaria
3
Galderma Investigational Site
Sofia, Bulgaria
4
Galderma Investigational Site
Chomutov, Czechia