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

Novartis

Status and phase

Completed

Phase 4

Conditions

Atopic Dermatitis

Treatments

Drug: Pimecrolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00139581

CASM981C2314

Details and patient eligibility

About

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".

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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