EUCTR2009-013792-22-DE进行中（未招募）不适用
A Phase 2, proof of concept and dose finding study, investigating treatment efficacy of LEO 29102 cream (2.5 mg/g, 1.0 mg/g, 0.3 mg/g, 0.1 mg/g, 0.03 mg/g), LEO 29102 cream vehicle, and Elidel (Pimecrolimus) cream 10 mg/g, after cutaneous administration twice daily for 4 weeks.An international, multi-centre, prospective, randomised, double-blind, 7 arm, vehicle-controlled, parallel group study - LEO 29102 Cream in the Treatment of Atopic Dermatitis
EO Pharma A/S0 个研究点目标入组 175 人开始时间: 2009年10月6日最近更新:
适应症
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
- 175
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
- •1. Clinical diagnosis of atopic dermatitis defined
- •according to Hanifin and Rajka.
- •2. IGA assessment scored as mild (2) to moderate (3)
- •atopic dermatitis.
- •3. Treatment lesions located on the trunk and/or limbs.
- •4. Treatment lesions involving 3% to 10% of the total
- •body surface area.
- •5. Patients of either gender between 18 years and 65
- •years of age.
- •6. Female patients on:
- •- hormonal contraceptives (used as a pill, patch,
- •ring and implant or as an injection) for at least
- •one menstrual cycle prior to randomisation:
- •* combined contraceptives containing both an
- •estrogen and a progestin
- •* progestogen-only contraceptives containing
- •only progesterone or a synthetic analogue
- •(progestin)
- •- intra uterine devices which are combined with a
- •hormone for at least one menstrual cycle prior to
- •randomisation
- •in Germany, contraceptive regimens must have been
- •used for at least 12 weeks before Visit 1, and the
- •patients must agree to continue their contraception
- •during the trial and for 1 month after the last application
- •of an investigational product in this trial.
- •7. Following verbal and written information about the
- •trial, the patient must provide signed and dated informed
- •consent before any study related activity is
- •carried out, including activities relating to the washout
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Systemic treatment with immunosuppressive drugs
- •(e.g., methotrexate, cyclosporine, azathioprine) or
- •corticosteroids within 6 weeks prior to randomisa-
- •tion. (Inhaled or in-tranasal steroids corresponding to
- •doses up to 1 mg prednisone may be used).
- •2. Topical treatment with immunomodulators (pimecrolimus,
- •tacrolimus) within 2 weeks prior to randomisation.
- •3. Topical treatment with corticosteroids from WHO
- •groups II, III or IV within 1 week prior to randomisation.
- •4. Use of topical or systemic antibiotics within 2 weeks
- •prior to randomisation.
- •5. Other topical therapy on the treatment areas within 1
- •week prior to randomisation. Note: use of emollient is
- •permitted on AD lesion during a washout period only
- •and on body areas not to be treated with investigational
- •product. Use of hydrocortisone cream 1% is permitted
- •on AD lesions on the face, neck and hands.
- •6. Change in systemic anti-histamine therapy within
- •two weeks prior to randomisation, i.e., the patients
- •should not start anti-histamine treatment or change
- •current dosage regimen within two weeks prior to
- •randomisation.
- •7. PUVA or UVB therapy within 4 weeks prior to
- •randomisation.
- •8. Clinical infection (viral, fungal or bacterial) on the
- •treatment area.
- •9. Known or suspected severe renal insufficiency or
- •severe hepatic disorders.
- •10. Patients with history of an immunocompromised
- •disease (e.g., lymphoma, HIV, Wiskott-Aldrich Syndrome).
- •11. Patients with concomitant serious disease (e.g.,
- •cancer) which might affect the AD treatment in this
- •12. Planned extensive sun exposure of treatment areas
- •during trial participation (e.g., sun bathing, use of
- •solarium, etc.).
- •13. Known or suspected hypersensitivity to component(
- •s) of the investigational product or comparator
- •(Elidel® cream (pimecrolimus) 10 mg/g).
- •14. Females who are pregnant or are breast feeding.
- •15. Females intending to temporarily or permanently
- •stop their hormonal contraceptive regime during and
- •up to one month post study termination Visit.
- •16. Current or within 4 weeks participation in any other
- •interventional clinical trial.
- •17. Previously randomised in this study.
- •18. In the opinion of the Investigator unlikely to comply
- •with the Clinical Study Protocol.
研究者
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