EUCTR2004-000940-26-AT进行中（未招募）不适用
A 22-week randomized, multicenter, parallel-group, double-blind study to compare a pimecrolimus 1% (Elidel) twice daily (B.I.D.) maintenance dosing regimen to a once daily (O.D.) maintenance dosing regimen in the management of atopic dermatitis in pediatric subjects - C2314
ovartis Pharma0 个研究点目标入组 262 人开始时间: 2004年9月30日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 262
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •(estimated using the subject’s palm of the hand as approximately 1% TBSA)
- •outpatients
- •subject (or primary caregiver) has been informed of the study procedures and
- •requirements and has signed the approved informed consent form (and patient assent form if applicable)
- •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.
- •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
排除标准
- •Exclusion criteria - Screening/Run-In period
- •subjects who applied topical therapy (e.g. tar, topical corticosteroids, pimecrolimus
- •(Elidel®) or tacrolimus (Protopic®) 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 (e.g. Neoral®,
- •Cyclosporine®, Prograf®, methotrexate, etc.) within 4 weeks of Screening
- •subjects who received systemic steroids (e.g. oral, intravenous, intra-articular, rectal) for any reason within 4 weeks of Screening
- •females who are pregnant or breast-feeding, or planning to become pregnant during the study
- •females who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (required during study and up to 4 weeks post-treatment). A medically approved” method of contraception may include abstinence at the discretion of the investigator. (A negative urine pregnancy test is required for all females of childbearing potential at Screening)
- •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,
- •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
- •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
- •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 (whichever occurred first)
- •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 i
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