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

NCT ID: NCT00139581

Last Updated: 2008-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2005-09-30

Brief Summary

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".

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, children, infants, pimecrolimus, bid, od

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Pimecrolimus b.i.d.

Group Type: EXPERIMENTAL

Pimecrolimus

Intervention Type: DRUG

Pimecrolimus cream 1 % applied twice daily (b.i.d.)

2

Pimecrolimus o.d. and placebo o.d.

Group Type: EXPERIMENTAL

Pimecrolimus

Intervention Type: DRUG

Pimecrolimus cream 1 % applied once daily (o.d.) and placebo applied once daily (o.d.)

Interventions

Pimecrolimus

Pimecrolimus cream 1 % applied twice daily (b.i.d.)

Intervention Type: DRUG

Pimecrolimus

Pimecrolimus cream 1 % applied once daily (o.d.) and placebo applied once daily (o.d.)

Intervention Type: DRUG

Other Intervention Names

Elidel b.i.d.; Elidel o.d.

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis Pharma AG

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

This study is not being conducted in the United States

Novartis Pharma AG, Basel, Switzerland

Countries

Switzerland

Other Identifiers

CASM981C2314

Identifier Type: -

Identifier Source: org_study_id