NCT01037881已完成2 期
A Phase 2, Proof of Concept and Dose Finding Study, Investigating Treatment Efficacy of LEO 29102 Cream, LEO 29102 Cream Vehicle, and Elidel® Cream 10 mg/g, After Cutaneous Administration Twice Daily for 4 Weeks
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 183
- 试验地点
- 3
- 主要终点
- Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF])
研究概览
简要总结
This is a proof of concept and dose finding Phase II trial comparing 5 dose strengths with vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment regimen in mild to moderate atopic dermatitis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of atopic dermatitis defined according to Hanifin and Rajka
- •IGA assessment scored as mild (2) to moderate (3) atopic dermatitis
- •Treatment lesions located on the trunk and limbs
- •Treatment lesions involving 3% to 10% of the total body surface area
- •Patients of either gender between 18 years and 65 years of age
排除标准
- •Systemic treatment with immunosuppressive drugs or corticosteroids within 6 weeks prior to randomisation
- •Topical treatment with immunomodulators (pimecrolimus, tacrolimus) within 2 weeks prior to randomisation
- •Topical treatment with corticosteroids from WHO groups II, III or IV within 1 week prior to randomisation
- •Use of topical or systemic antibiotics within 2 weeks prior to randomisation
- •PUVA or UVB therapy within 4 weeks prior to randomisation
- •Clinical infection (viral, fungal or bacterial) on the treatment area
- •Known or suspected severe renal insufficiency or severe hepatic disorders
- •Patients with history of an immunocompromised disease (e.g., lymphoma, HIV, Wiskott-Aldrich Syndrome)
- •Patients with concomitant serious disease (e.g., cancer) which might affect the AD treatment in this trial
- •Females who are pregnant or are breast feeding
- •Females intending to temporarily or permanently stop their hormonal contraceptive regime during and up to one month post study termination visit
研究组 & 干预措施
LEO 29102 0.03 mg/g cream
Experimental
干预措施: LEO 29102 (Drug)
LEO 29102 0.1 mg/g cream
Experimental
干预措施: LEO 29102 (Drug)
LEO 29102 0.3 mg/g cream
Experimental
干预措施: LEO 29102 (Drug)
LEO 29102 1.0 mg/g cream
Experimental
干预措施: LEO 29102 (Drug)
LEO 29102 2.5 mg/g cream
Experimental
干预措施: LEO 29102 (Drug)
LEO 29102 cream vehicle
Placebo Comparator
干预措施: LEO 29102 (Drug)
Elidel® cream (pimecrolimus) 10 mg/g
Active Comparator
干预措施: Elidel® (Drug)
结局指标
主要结局
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF])
时间窗: Baseline (Day 0) and end of treatment (Day 28)
The EASI is a composite score based on the evaluation of four characteristic atopic dermatitis (AD) signs and symptoms; erythema, oedema/induration/papulation, excoriation and lichenification together with the area involved. For each body region, the investigator rated four clinical signs of AD using the following severity scale: 0 = none/absent 1. = mild 2. = moderate 3. = severe The EASI score ranges from 0-12, a higher score equals a worse outcome. Baseline was defined as Day 0. Mean values in table are least squares mean adjusted for the effect of (pooled) country.
次要结局
- Number of Participants That Were Symptom Free Responders by Visit(At Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21) and end of treatment (Day 28))
- Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit(Baseline and at Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21))
- Participants' Overall Assessment of Disease Severity(At end of treatment (Day 28))
- Participants' Assessment of Pruritus on Trunk and Limbs(At end of treatment (Day 28))
- Number of Participants That Were Symptom Free Responders (LOCF)(At end of treatment (Day 28))
研究者
研究点 (3)
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