Phase 3 Papulopustular Rosacea Study

Galderma

Status and phase: Completed; Phase 3

Conditions: Papulopustular Rosacea (PPR)

Treatments: Drug: Azelaic acid 15% Gel; Drug: CD5024

Study type: Interventional

Funder types: Industry

Identifiers

NCT01493687

RD.06.SPR.18170

Details and patient eligibility

About

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.

Enrollment: 683 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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,
2. The subject has rosacea with more than two nodules on the face.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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683 participants in 2 patient groups, including a placebo group

CD5024

Experimental group

Description:

CD5024 1% Cream

Treatment:

Drug: CD5024

CD5024 Vehicle

Placebo Comparator group

Description:

CD5024 Vehicle Cream

Treatment:

Drug: Azelaic acid 15% Gel