EUCTR2007-003106-99-DE进行中（未招募）不适用
Pimecrolimus and Epidermal Barrier Function: Role for pimecrolimus in restoring skin barrier function and normalizing epidermal lipid content and differentiation in atopic epidermis: a randomized, intra-patient, double-blind (right/left arm) study in adults with atopic dermatitis treated with 1% pimecrolimus cream and 0.1% triamcinolone acetonide cream as treatment control twice daily for 3 weeks - Pimecrolimus and Epidermal Barrier Function
niversity of Kiel, Department of Dermatology0 个研究点开始时间: 2007年8月17日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Subjects may be included only if the following apply at the baseline visit (day 0, before first application of study medication).
- •Patients to be included are:
- •·Males and females of any race.
- •· >= 18 years old.
- •·Have atopic dermatitis as defined by Hanifin and Rajka criteria.
- •·History of mild to moderate atopic dermatitis
- •·At least 10 % of each upper limb affected by atopic dermatitis excluding the surface area of the hands, as these will not be treated in order to avoid cross-contamination. As reference: one hand (palm and fingers) corresponds to 10% of patient’s upper limb surface.
- •·One specific, representative area of the disease on each upper limb with similar size and severity on both upper limbs. These will be considered the target lesions.
- •·A target lesion score of at least 3 to 8 (on a scale of 0-12) for both right and left target lesions and not differing more than 1 score point between the right and left sides.
- •·Must be able to suspended treatment of atopic dermatitis with other therapies for the duration of the study (3-5 weeks).
- •·Must be informed of study procedures and have signed the informed consent form approved for the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. Females of childbearing potential and not practicing a medically approved method of contraception during and up to at least 4 weeks after the end of treatment. ‘Medically approved’ contraception may include implants, injectables, combined oral contraceptives, IUDs, but also abstinence at the discretion of the investigator.
- •Other therapies/medications:
- •·Prior phototherapy or systemic therapy known to or suspected to have an effect on atopic dermatitis within 14 days prior to first application of study medication. Patients on a low stable dose of inhaled steroids (dose known to have negligible systemic absorption) and systemic antihistamines may participate.
- •·Topical therapy known to or suspected to have an effect on atopic dermatitis (including topical steroids, topical tacrolimus ointment or topical pimecrolimus cream) on the upper limbs within 7 days prior to first application of study medication.
- •·Topical therapy known to or suspected to have an effect on atopic dermatitis on other areas than upper limbs if total body surface treated is higher than 20% (due to the higher risk of systemic absorption affecting the lesions of the upper limbs) within 7 days prior to first application of study medication
- •Concurrent diseases / conditions and history of their diseases / conditions:
- •·Patients who have signs of skin atrophy and corticoid damage on the target areas
- •·Patients who are immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich Syndrome)
- •·Patients who have concurrent skin disease (e.g. impetigo) on or near the study area which could interfere with study evaluations
- •·Patients who have acute viral skin infections (e.g. herpes simplex, varicella zoster)
- •Investigational drug / therapy use.
- •·Patients who have used investigational drugs within 8 weeks prior to first application of study medication or intend to use other investigational drugs during the course of the study
- •Ingredient hypersensitivity
- •·Patients with known hypersensitivity to any ingredient of the study medication (see technical information sheet)
- •Compliance / reliability / investigator judgment
- •·Patients who are, in the opinion of the investigator, known to be unreliable or non-compliant with medical treatment, or are known to miss appointments (according to patient records)
- •·Patients who have drug abuse problems, mental dysfunction or other factors limiting their ability to cooperate fully
- •·Patients who have any other condition or prior/present treatment which, in the opinion of the investigator, will render the patient ineligible for the study
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