A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the Face

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Seborrheic Dermatitis on the Face

Treatments: Drug: Inactive 15% gel base; Drug: Azelaic Acid 15% Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00408330

1401201

2006-002060-26 (EudraCT Number)

Details and patient eligibility

About

This study is to determine whether a medication on the market for other indications is effective and safe in treating seborrheic dermatitis of the face.

Full description

To test the efficacy and safety of azelaic acid 15% gel in the treatment of seborrheic dermatitis of the face

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable or exacerbating seborrheic dermatitis in the facial area

Exclusion criteria

• Psoriasis
• Atopic dermatitis
• Facial acne and rosacea
• Dermatophytic skin infections
• Parkinson's disease
• Known immunosuppression; HIV infection
• Any condition requiring continuous systemic or topical corticosteroid or antimycotic therapy
• Continuous asthma inhalation treatment requiring > 800 mg corticosteroids
• Any severe disease likely to interfere with the conduct or the planned termination of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

azelaic acid 15%

Treatment:

Drug: Azelaic Acid 15% Gel

2

Placebo Comparator group

Description:

Inactive 15% gel base

Treatment:

Drug: Inactive 15% gel base