Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects

Study Overview
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Brief Summary
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This study is not being conducted in the United States. To investigate the relative efficacy of pimecrolimus cream 1% applied twice daily (b.i.d.) versus once daily (o.d.) in preventing the progression to disease relapse.

Official Title
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Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Pimecrolimus
* Drug: Pimecrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion criteria - Screening/Run-In Period age >= 2 years through age <=17 years of age IGA score of 2, 3, or 4 (mild, moderate, or severe AD) affecting >5% TBSA outpatients Exclusion Criteria:Screening/Run-In period subjects who applied topical therapy (e.g. tar, topical corticosteroids) within 2 weeks prior to Screening subjects who received phototherapy (e.g. UVB, PUVA, Narrow Band) within 4 weeks of Screening subjects who received any systemic immunosuppressant subjects who received systemic steroids females who are pregnant or breast-feeding, or planning to become pregnant during the study subjects who are immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome) or have a history of malignancy (includes basal cell carcinoma, squamous cell carcinoma, melanoma) subjects with open skin infections (bacterial, viral or fungal) if at the application site. subjects will HSV (common cold sores) are allowed to participate in the study (if not at the application site). subjects who have head lice or scabies subjects who present with clinical conditions other than AD that may interfere with the evaluation (e.g., generalized erythroderma, acne, Netherton's Syndrome,psoriasis) subjects that require systemic therapy for the treatment of atopic dermatitis subjects with poor or no clinical response to tacrolimus ointment (Protopic®) or pimecrolimus cream 1% subjects who used any experimental or investigational drug or therapy within 6 weeks prior to Screening subjects who intend to use experimental or investigational drug therapy during the course of this study subjects with known hypersensitivity to pimecrolimus 1% or related drugs (see Investigator's Brochure) subjects who are non-compliant with general medical treatment, or are known to miss appointments, or don't intend to comply with the protocol for the duration of the study drug abuse, mental dysfunction, or other factors limiting the subject's ability to cooperate fully with study-related procedures subjects known to be unreliable or may be unable to complete the study any condition or prior/present treatment that would render the subject ineligible for the study Inclusion criteria - Double-blind Maintenance treatment period - Achieve complete remission of active disease (no signs or symptoms of AD) without incidence of relapse by the end of 6-week Run-In period (may be earlier); or who achieve disease improvement (decrease in IGA score by 1 full point confirmed by the investigator) without incidence of relapse at the end of the 6-week Run-In period Exclusion criteria - Double-blind Maintenance treatment period subjects who experienced a relapse during the Run-In period subjects who applied topical corticosteroids or any alternative or additional therapy for the treatment of AD during the Run-In period subjects with active skin infections (bacterial, viral or fungal) except common cold sores (HSV) at the application site subjects who failed to record study medication use (and non use) and dosing regimen during the Run-In period subjects who failed to apply open label study drug twice daily until disease remission or end of the 6 week Run-In period subjects who failed to record concomitant medications during the Run-In period failure to return open-label study drug (used, partially used, and unused tubes) at the time double-blind study drug is dispensed. In order to avoid medication error, all open label study drug must be returned to the site before starting the Maintenance period

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pimecrolimus b.i.d. | Drug: Pimecrolimus<br>* Pimecrolimus cream 1 % applied twice daily (b.i.d.)<br>* Other names: Elidel b.i.d.;|
| Experimental: 2<br>Pimecrolimus o.d. and placebo o.d. | Drug: Pimecrolimus<br>* Pimecrolimus cream 1 % applied once daily (o.d.) and placebo applied once daily (o.d.)<br>* Other names: Elidel o.d.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to relapse of atopic dermatitis (defined as the exacerbation of atopic dermatitis to the level where a topical corticosteroid or alternative therapy is required). |  |  | 
| Investigators Global Assessment (IGA) and pruritus (itch) assessment of atopic dermatitis at time of suspected relapse |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first recurrence of atopic dermatitis |  |  | 
| Eczema Area and Severity Index (EASI) and IGA assessments at several time points. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic dermatitis, children, infants, pimecrolimus, bid, od