A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis

Bayer

Status and phase: Completed; Phase 4

Conditions: Mild to Moderate Atopic Dermatitis

Treatments: Device: Zarzenda; Drug: Elidel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00568412

1401920

Details and patient eligibility

About

To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis

Enrollment: 80 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male and female children and adolescents (aged 2 - 17)
• mild to moderate atopic dermatitis
• patients in whom a treatment with topical corticosteroids in not recommended or possible
• wash out periods to be observed

Exclusion criteria

• known allergy to one of the two treatments
• known immunodeficiency
• known hepatic or renal insufficiency
• acute skin infections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

1

Active Comparator group

Description:

Zarzenda applied topically twice daily for three weeks

Treatment:

Device: Zarzenda

2

Active Comparator group

Description:

Elidel 1% cream, applied topically twice daily for three weeks

Treatment:

Drug: Elidel