Overview

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

Status:
Completed

Trial end date:
2013-12-01

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Galderma R&D

Treatments:

Ivermectin
Metronidazole

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.