NCT00139581已完成4 期
Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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
研究组 & 干预措施
1
Experimental
Pimecrolimus b.i.d.
干预措施: Pimecrolimus (Drug)
2
Experimental
Pimecrolimus o.d. and placebo o.d.
干预措施: Pimecrolimus (Drug)
结局指标
主要结局
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
次要结局
- Time to first recurrence of atopic dermatitis
- Eczema Area and Severity Index (EASI) and IGA assessments at several time points.
研究者
研究点 (1)
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