EUCTR2006-001472-20-DK进行中（未招募）1 期
EO19123 Cream in the Treatment of Atopic DermatitisA Phase II, proof of concept study, testing once daily use of two dose-combinations of LEO19123 cream (calcipotriol and LEO80122) in the treatment of atopic dermatitis - LEO19123 Cream in the Treatment of Atopic Dermatitis
EO Pharma A/S0 个研究点目标入组 75 人开始时间: 2006年7月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
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
- Male
入选标准
- •1. Signed informed consent has been obtained following verbal and written
- •information about the trial
- •2. Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka (see
- •Appendix III)
- •3. The score of each of the five clinical signs in Total Severity Score on the arms
- •should be =2 (moderate) at Visit 1
- •4. Treatment area amenable to topical treatment
- •5. Male gender
- •6. Age between 18-50 years
- •7. Attending a hospital outpatient clinic or the private practice of a dermatologist
- •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 4 weeks prior to
- •randomisation. (Inhaled or in-tranasal steroids for asthma or rhinitis may be
- •2. PUVA or UVB therapy within 4 weeks prior to randomisation
- •3. Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or cortico-
- •steroids from WHO groups III or IV within 2 weeks prior to randomisation
- •4. Other topical therapy on the treatment area (except for the use of emollient on
- •the entire body and hydrocortisone cream 1% on head and neck lesions) within
- •1 week prior to randomisation
- •5. Use of any other kind of treatment for AD (drug , non-drug) during the study
- •except for the use of:
- •- investigational product on trunk and limbs lesions only during the treatment
- •- hydrocortisone cream 1% on head and neck lesions
- •- emollient on the entire body
- •6. Use of anti-histamines during the study
- •7. Current diagnosis of exfoliative erythrodermia
- •8. Clinical infection (impetiginised atopic dermatitis) on the treatment area
- •9. Planned exposure to amount of sun or ultraviolet light during the study that may
- •affect atopic dermatitis
- •10. Known or suspected hypersensitivity to component(s) of the investigational
- •11. Known or suspected severe renal insufficiency or severe hepatic disorders
- •12. Patients with history/signs/symptoms suggestive of an abnormality of calcium
- •homeostasis associated with clinically significant hypercalcaemia
- •13. Patients with history of cancer including skin cancer
- •14. Patients with history of an immunocompromised disease (e.g. lymphoma, HIV,
- •Wiskott-Aldrich Syndrome)
- •15. Current participation in any other interventional clinical trial
- •16. Patients who have received treatment with any non-marketed drug substance
- •(i.e. an agent which has not yet been made available for clinical use following
- •registra-tion) within 4 weeks prior to randomisation
- •17. Previously randomised in this study
- •18. Patient known or, in the opinion of the investigator, is unlikely to comply with
- •the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state)
研究者
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