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.

• Conditions: Mild to moderate atopic dermatitis.; MedDRA version: 9.1Level: LLTClassification code 10003639Term: Atopic dermatitis

• Registration Number: EUCTR2007-002133-36-DE
• Lead Sponsor: INTENDIS GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-10
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1.Fully informed written consent of the legal representative and assent of the patient
2.Mild to moderate atopic dermatitis according to the Investigator’s Global Assessment (IGA 3 or 4)
3.History of atopic dermatitis for at least one year
4.Age of 2 – 17 years at baseline
5.Affected Body Surface Area (BSA): minimum of 5%
6.Patients in whom a treatment with topical corticosteroids is not recommended or is not possible, i.e. due to intolerability of topical corticosteroids, due to lack of efficacy of topical corticosteroids, due to use in the face and the neck where the use of topical corticosteroids is not recommended.
7.Wash out periods to be observed before start of study medication:
•At least 4 weeks have passed since any use of systemic therapy for atopic dermatitis (AD), e. g., systemic corticosteroids (including inhaled or intranasal > 1mg/d), cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy
•At last 4 weeks have passed since any vaccination
•At least 4 weeks have passed since local AD therapy using tacrolimus or pimecrolimus
•At least 2 weeks have passed since antihistaminic therapy, unless taken regularly during the previous year
•At least 2 weeks have passed since local AD therapy using corticosteroids
8.At least 4 weeks have passed since participation in an investigational drug study
9.Willingness to follow all study procedures
10.Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnancy (in patients with childbearing potential), breast feeding
2.Indication for systemic therapy of the atopic dermatitis
3.Known sensitivity to Zarzenda®, and / or to any excipients of the formulation and/or to an extract of the nut butyrospermum parkii (shea)
4.Known sensitivity to macrolides
5.Lymphadenopathy
6.Known immune deficiency
7.Known hepatic insufficiency
8.Known renal insufficiency
9.Patients with severe excoriations
10.Patients with clinically active skin infection (e.g. acute and severe impetigo contagiosa)
11.Acute herpes simplex, mononucleosis, or mollusca contagiosa infection
12.Severe other viral, bacterial, or fungal skin infection (chicken pox, tinea corporis)
13.Acute infestations (e.g. head lice, scabies)
14.Generalized erythroderma, Netherton’s syndrome,
15.Any conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
16.Patient is a dependent person, e.g., a relative / family member of the investigator and / or is a member of the investigator’s staff

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to show therapeutic efficacy of Zarzenda® cream versus Elidel® 1% cream in children and adolescents with mild to moderate atopic dermatitis . ;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint will be the Investigator's Global Assessment (IGA) dichotomized as ‘success/failure’ by combining the scores in ‘clear’/‘almost clear’ and ‘mild’/‘moderate’/ ‘severe’/‘very severe’. The Investigator Global Assessment (IGA) score will be assessed at baseline and at each treatment visit. The investigator will assess the current overall clinical picture of the patient, i.e. the Investigator’s Global Assessment is a static score which takes into account only the actual disease severity. The use of a static score has the advantage that the investigator does not need to remember the individual baseline of a patient.