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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00139581

Collaborator

(none)

Location

Arms

Duration (Months)

Study Details

Study Description

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".

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Pimecrolimus Drug: Pimecrolimus	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2004

Actual Study Completion Date :

Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Pimecrolimus b.i.d.	Drug: Pimecrolimus Pimecrolimus cream 1 % applied twice daily (b.i.d.) Other Names: Elidel b.i.d.
Experimental: 2 Pimecrolimus o.d. and placebo o.d.	Drug: Pimecrolimus Pimecrolimus cream 1 % applied once daily (o.d.) and placebo applied once daily (o.d.) Other Names: Elidel o.d.

Arm

Intervention/Treatment

Experimental: 1

Pimecrolimus b.i.d.

Drug: Pimecrolimus

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

Other Names:

Elidel b.i.d.

Experimental: 2

Pimecrolimus o.d. and placebo o.d.

Drug: Pimecrolimus

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

Other Names:

Elidel o.d.

Outcome Measures

Primary Outcome Measures

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

Time to first recurrence of atopic dermatitis []
Eczema Area and Severity Index (EASI) and IGA assessments at several time points. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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