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

A Multicenter, Randomized, Double-blind Clinical Study to Examine the Efficacy and Safety of Zarzenda in Comparison to Elidel in the Management of Mild to Moderate Atopic Dermatitis in Children and Adolescents

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00568412

Enrollment

Registered

2007-12-06

Start date

2007-12-31

Completion date

2008-09-30

Last updated

2015-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to Moderate Atopic Dermatitis

Keywords

atopic dermatitis

Brief summary

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

Interventions

DEVICEZarzenda

Topical cream, applied twice daily for three weeks

DRUGElidel

1% cream, applied topically twice daily for three weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame
Investigator's Global Assessment	End of study compared to baseline

Secondary

Measure	Time frame
EASI	End of study compared to baseline
Affected body surface area	End of study compared to baseline
Patient's assessment of itch, quality of sleep, and global assessment	End of study compared to baseline
Children's Dermatological Life Quality Index	End of study compared to baseline

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026