comparison of pimecrolimus cream 1% twice-daily to once-daily dosing in the management of atopic dermatitis in pediatric subjects

Conditions: Atopic Dermatitis

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".


Eligibility 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

Keywords: atopic dermatitis, children, infants, pimecrolimus, bid, od