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Adjusted LOA
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ACZONE, 5%, 2x/day · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Vehicle control, 2x/day | DRUG | - |
| ACZONE (dapsone) Gel, 5%, 2x/day | DRUG | - |
| ACZONE (dapsone) Gel, 5%, 1x/day | DRUG | - |
| MetroGel® (metronidazole gel), 1.0% 1x/day | DRUG | - |
| ACZONE (dapsone) Gel, 5%, 1x/day (AM) + MetroGel (metronidazole gel), 1.0%, 1x/day (PM) | DRUG | - |
Inclusion Criteria: To be eligible for the study, subjects must fulfill all of the following criteria: 1. Men or women ≥18 years of age. 2. A diagnosis of papulopustular rosacea, with ≥10 inflammatory lesions (papules and/or pustules) above the mandibular line at baseline. 3. An Investigator Globa...
ACZONE, 5%, 2x/day is a dapsone gel formulation being studied for papulopustular rosacea, a dermatologic condition. It is applied twice daily. The asset is in Phase 2 clinical development and is not approved for this use; it remains investigational.
ACZONE, 5%, 2x/day is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating this dapsone gel formulation in rosacea.
ACZONE, 5%, 2x/day is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved for papulopustular rosacea.
ACZONE, 5%, 2x/day has been evaluated in one completed Phase 2 trial, NCT00249782, titled A Phase II, Randomized Study of ACZONE (Dapsone) Gel, 5% for Papulopustular Rosacea. The trial enrolled 400 participants in the United States and included adults 18 years and older of all sexes.
The Phase 2 trial NCT00249782 was randomized, with 400 participants enrolled, and was not double blind. It used an uncontrolled design without a control arm. Participants were adults 18 years and older of all sexes, and the study was conducted in the United States.