Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Papulopustular Rosacea

Treatments: Drug: Azelaic acid; Drug: Vehicle foam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00617903

1402140

Details and patient eligibility

About

This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male and female patient at least 18 years of age
• signed informed consent
• Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia
• Ability and willingness to accept and comply with treatment and required medical examinations

Exclusion criteria

• Known non-responders to azelaic acid
• Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea
• Presence of dermatoses that could interfere with the rosacea diagnosis
• Treatment with isotretinoin in the six months prior to randomization
• Treatment of the face with topical retinoids during the two weeks prior to randomization
• Treatment with oral antibiotics during the four weeks prior to randomization
• Treatment with topical antibiotics
• Treatment with systemic corticosteroids during 4 weeks prior to randomization
• Treatment of the face with topical corticosteroids during 2 weeks prior to randomization
• Treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization
• Treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization
• Use of a sauna during 2 weeks prior to randomization and during the study
• Facial laser surgery for telangiectasia during 6 weeks prior to randomization
• Planned concurrent use of any treatment other than study medication that affects rosacea
• History of hypersensitivity to propylene glycol or any other ingredient of the study drugs
• Participation in another clinical trial during the last 4 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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83 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

Vehicle foam

Placebo Comparator group

Description:

Participants received vehicle foam topically twice daily for 12 weeks

Treatment:

Drug: Vehicle foam