Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Azelaic Acid Foam · 2 trials · 1 indication
Static evaluation of overall severity of papulopustular rosacea at a given time: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.
The mean (standard deviation) change from baseline in the inflammatory lesion count at the end of treatment is provided.
| Arm | Type | Description |
|---|---|---|
| Azelaic acid foam, 15% (BAY39-6251) | EXPERIMENTAL | 0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks. |
| Vehicle foam | PLACEBO_COMPARATOR | 0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks. |
| Azelaic Acid Foam 15% | EXPERIMENTAL | Dermal application of Azelaic Acid Foam 15% |
| Azelaic Acid Gel 15% | ACTIVE_COMPARATOR | Dermal application of Azelaic Acid Gel 15% |
| Name | Type | Description |
|---|---|---|
| Azelaic acid foam, 15% (BAY39-6251) | DRUG | Azelaic acid twice daily topical application |
| Vehicle foam | DRUG | twice daily topical application |
| Azelaic Acid Foam | DRUG | Dermal application of Azelaic Acid Foam |
| Azelaic Acid Gel | DRUG | Dermal application of Azelaic Acid Gel |
Inclusion Criteria: * Diagnosis of papulopustular rosacea * Free of any clinically significant disease, which could interfere with the study * Male or female subject aged ≥ 18 years * Willingness of subject to follow all study procedures * Signed written informed consent before any study-related ac...
Azelaic Acid Foam is used for the treatment of papulopustular rosacea, a form of rosacea characterized by redness and pus-filled bumps. It is a small molecule dermatology therapy being developed by Bayer AG. The drug is currently in Phase 3 clinical development for this indication.
Azelaic Acid Foam is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is in Phase 3 clinical development for the treatment of papulopustular rosacea, a dermatological condition.
Azelaic Acid Foam is in Phase 3 clinical development for the treatment of papulopustular rosacea. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial, NCT01555463, evaluated the safety and efficacy of the 15% foam formulation in 961 patients.
Azelaic Acid Foam has been studied in two completed clinical trials for papulopustular rosacea. NCT01257919 was a Phase 1 safety and pharmacokinetics study with 21 participants, and NCT01555463 was a Phase 3 safety and efficacy study with 961 participants. Both trials were conducted in the United States.
Azelaic Acid Foam is a foam formulation of azelaic acid, a small molecule used in dermatology. The drug is specifically being developed as a 15% foam for the treatment of papulopustular rosacea. It is an investigational product in Phase 3 clinical development.