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

Galderma

Status and phase: Completed; Phase 3

Conditions: Papulopustular Rosacea

Treatments: Drug: Metronidazole 0.75% cream; Drug: Ivermectin 1% cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT01493947

RD.03.SPR.40173

Details and patient eligibility

About

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

Enrollment: 962 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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962 participants in 2 patient groups

Ivermectin 1% cream

Experimental group

Treatment:

Drug: Ivermectin 1% cream

Metronidazole 0.75% cream

Active Comparator group

Treatment:

Drug: Metronidazole 0.75% cream