A 16-week, randomized, multi-center, parallel-group, pimecrolimus-blinded, controlled study (4-week treatment period followed by 12-week observational period) to evaluate the safety of concomitant use of ASM 981 (pimecrolimus) cream 1% (BID) plus topical corticosteroid (BID) for the treatment of severe atopic dermatitis in patients 2 to 17 years of age

ovartis Pharma Services AG0 个研究点目标入组 400 人开始时间: 2006年5月9日最近更新: 2012年4月24日

适应症

试验速览

暂无简介。

•Who are males and females aged 2 to 17 years, inclusive
•Who have AD affecting > 5% of total body surface area excluding the face (estimated using the patient’s palm of the hand as approximately 1% TBSA)
•Who have an overall Investigator’s Global Assessment (IGA) score of 4 or greater (severe/very severe)
•Who have diagnosis of AD fulfilling the Williams criteria (Williams 2000)
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Who have concurrent skin disease (e.g. acne) in the study area or active skin infections (active bacterial, viral or fungal infections or infestations, herpes simplex, herpes zoster, chicken pox), or other conditions that may interfere with the evaluation (e.g. generalized erythroderma such as the genetic condition, Netherton’s syndrome, or other skin condition such as psoriasis)
•Who are immunocompromised (e.g. Lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history or presence of malignant disease
•Who have previously reported poor, no clinical response, or hypersensitivity to topical tacrolimus ointment (Protopic®) or pimecrolimus cream (Elidel®)
•Who are not responsive to topical corticosteroid treatment or have reported adverse reactions to topical corticosteroids
•Who have had topical therapy (e.g. tar, topical corticosteroid) known or suspected to have a therapeutic effect on atopic dermatitis within 4 days prior to first application of study medication
•Who have received phototherapy (e.g. UVA, UVB) or systemic therapy (e.g. immunosuppressants, cyclosporine, corticosteroids, cytostatics) known or suspected to have an effect on AD within 4 weeks prior to the first application of study medication
•Who have received investigational drugs within 8 weeks of first application of study drug or planned use of other investigational drugs during participation of this study
•Who have abnormally functioning HPA-axis as determined by plasma cortisol measurement

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