EUCTR2006-002686-39-GB进行中（未招募）1 期
EO19123 Cream in the Treatment of Hand Eczema A Phase II, proof of concept study, testing once daily use of two dose-combinations of LEO19123 cream (calcipotriol and LEO80122) in the treatment of hand eczema - LEO19123 Cream in the Treatment of Hand Eczema
EO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S)0 个研究点目标入组 75 人开始时间: 2006年7月22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
入选标准
- •1. Clinical diagnosis of hand eczema with or without atopic etiology/background
- •2. Investigator’s Global Assessment of disease severity graded as at least mild at
- •3. Patients should be Caucasian males aged from 18 years
- •4. Attending a hospital outpatient clinic or the private practise 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) yes
- •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 intra-nasal steroids for asthma or rhinitis may be used)
- •2. PUVA or UVB therapy on the hands within 4 weeks prior to randomisation
- •3. Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or corticoster
- •-oids from WHO groups III or IV on the hands within 2 weeks prior to
- •randomisation
- •4. Other topical therapy on the hands (except for the use of emollients) within 1
- •week prior to randomisation
- •5. Use of other treatment (drug, non-drug) on the hands during the study except for
- •the use of investigational product and emollient
- •6. Concurrent skin diseases on the hands
- •7. Current diagnosis of exfoliative dermatitis
- •8. Significant clinical infection (impetiginised hand eczema) on the hands which
- •requires antibiotic treatment
- •9. Known or suspected hypersensitivity to component(s) of the investigational
- •10. Positive patch test as defined in section 11.7.4.2 of the protocol.
- •11. Known or suspected severe renal insufficiency or severe hepatic disorders
- •12. Patients with history/signs/symptoms suggestive of an abnormality of calcium
- •homeo-stasis associated with clinically significant hypercalcaemia
- •13. Patients with history of cancer except for basal cell carcinoma
- •14. Current participation in any other interventional clinical trial
- •15. 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
- •registration) within 4 weeks prior to randomisation
- •16. Previously randomised in this study
- •17. Patients 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
相似试验
进行中（未招募）
1 期
EO19123 Cream in the Treatment of Atopic Dermatitis A 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 DermatitisMedDRA version: 8.1 Level: LLT Classification code 10003639 Term: Atopic dermatitisAtopic dermatitisEUCTR2006-001472-20-GBEO Pharmaceutical Products Ltd A/S (LEO Pharma A/S)75
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 DermatitisAtopic dermatitisEUCTR2006-001472-20-DKEO Pharma A/S75
进行中（未招募）
不适用
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 DermatitisMedDRA version: 8.1Level: LLTClassification code 10003639Term: Atopic dermatitisAtopic dermatitisEUCTR2006-001472-20-FIEO Pharma A/S75
已完成
2 期
LEO19123 Cream in the Treatment of Hand EczemaHand EczemaNCT00404196LEO Pharma75
招募中
1 期
Treatment of Chronic Hand Eczema with Oral Roflumilast (HERO)Chronic hand eczemaCTIS2022-503011-42-00Bispebjerg Hospital40