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”.

Condition	Intervention	Phase
Atopic Dermatitis	Drug: Pimecrolimus Cream 1%	Phase IV

Ages Eligible for Study:  2 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

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

Switzerland, Basel
      This study is not being conducted in the United States, Novartis Pharma AG,  Basel,  Switzerland

Study chairs or principal investigators

Novartis Pharma AG,  Study Chair,  Novartis   

Study ID Numbers:  ASM981C2314
Last Updated:  August 30, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00139581
Health Authority: Austria: Federal Ministry for Health and Women; Belgium: Directorate general for the protection of Public health: Medicines; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Spain: Spanish Agency of Medicines; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-09-13