Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea

LEO Pharma

Status and phase: Completed; Phase 3

Conditions: Papulopustular Rosacea

Treatments: Drug: Azelaic acid foam, 15% (BAY39-6251); Drug: Vehicle foam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01555463

1401846 (Other Identifier)

16080

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.

Full description

To determine the efficacy of AzA foam, 15% compared to vehicle topically applied twice daily in papulopustular rosacea evaluated by therapeutic success rate according to Investigators Global Assessment (IGA) and change in inflammatory lesion count from baseline to end of treatment.

Evaluation of all adverse events will be covered in Adverse Events section.

Enrollment: 961 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 activities are carried out

Exclusion criteria

• Subjects who are known to be non-responders to azelaic acid
• Presence of dermatoses that might interfere with rosacea diagnosis
• Ocular rosacea; phymatous rosacea; subjects with plaque-type rosacea lesions, papulopustular rosacea that requires systemic treatment
• Topical use of any prescription or non-prescription medication to treat rosacea within 6 weeks prior to randomization and throughout the study
• Systemic use of any prescription or non-prescription medication to treat rosacea (Retinoids within 6 months, Tetracycline within 2 months, Corticosteroids, erythromycin, azithromycin, and/or metronidazole within 4 weeks) prior to randomization and throughout the study
• Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization
• Known hypersensitivity to any ingredients of the investigational product formulation
• Participation in another clinical research in parallel or within the last 4 weeks before randomization in this study
• Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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961 participants in 2 patient groups, including a placebo group

Azelaic acid foam, 15% (BAY39-6251)

Experimental group

Description:

0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.

Treatment:

Drug: Azelaic acid foam, 15% (BAY39-6251)

Vehicle foam

Placebo Comparator group

Description:

0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.

Treatment:

Drug: Vehicle foam