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

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Papulopustular Rosacea

Treatments: Drug: Vehicle foam; Drug: Azelaic acid foam 15%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01025635

1403120 (Other Identifier)

14955

Details and patient eligibility

About

This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.

Enrollment: 401 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed written informed consent
• Diagnosis of papulopustular rosacea (IGA score of moderate or severe) with a minimum of 12 and maximum of 50 inflammatory lesions (papules and/or pustules) and persistent erythema with or without telangiectasia
• Free of any clinically significant disease which could interfere with the study
• Willingness to follow all study procedures
• Male or female patient at least 18 years of age

Exclusion criteria

• Subjects known to be non-responders to azelaic acid
• Presence of dermatoses that might interfere with the rosacea diagnosis or the evaluation of treatment results
• Ocular rosacea, phymatous rosacea
• Any condition or therapy that in the opinion of the investigator may pose a risk to the patient of interfere with any evaluation in the study
• Facial laser surgery in the 6 weeks prior to the study
• Topical or systemic use of prescription or non-prescription medications to treat rosacea
• Use of any agent other than the investigational drugs to treat rosacea during the study
• Expected use or change in dose in the 90 days prior to the study of beta-blockers, vasodilators, NSAIDs, hormonal treatment or drugs causing acneiform eruptions
• Known hypersensitivity to any ingredients of the investigational product formulation
• Alcohol or drug abuse
• Incapability of giving fully informed consent
• Subject is dependent person, i.e., a relative/family member of the investigator and/or is a member of the investigator's staff
• Participation in another clinical research study within the last 4 weeks before randomization in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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401 participants in 2 patient groups, including a placebo group

Azelaic acid foam, 15% (BAY39-6251)

Experimental group

Description:

Participants received azelaic acid foam, 15% topically twice daily for 12 weeks

Treatment:

Drug: Azelaic acid foam 15%

Vehicle foam

Placebo Comparator group

Description:

Participants received vehicle foam topically twice daily for 12 weeks

Treatment:

Drug: Vehicle foam