NCT00367393已完成4 期
An Open-label Multicenter 12-month Long Term Study on Skin Reconstitution With Pimecrolimus Cream 1% in Adult Patients With Atopic Eczema and Corticosteroid Induced Skin Damage
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- • Decrease of the Dermatophot (a combination of a dermatoscope and a camera) score on skin deterioration and spider veins from baseline to end of the study
研究概览
简要总结
Topical steroid use may lead to skin deterioration and spider veins. This study will examine long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and its effect on skin reconstitution of steroid-damaged skin and disease control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically diagnosed AD
- •almost clear to mild AD (local IGA [target lesions face and cubital areas] score of 1-3)
- •clinically (i.e. to the unaided eye) evident skin atrophy due to long-term topical steroid use
- •Dermatophot Score (DPS - composed of skin atrophy and telangiectasia) of 4-6 on at least two target areas
排除标准
- •Phototherapy or systemic therapy known or suspected to have an effect on AD within 4 weeks prior to study entry
- •Topical therapy known or suspected to have an effect on AD within 7 days prior to study entry or systemic corticosteroids within 4 weeks prior to study entry
- •Clinical conditions other than AD that according to investigator can interfere with the Dermatophot evaluation
研究组 & 干预措施
1
Experimental
Pimecrolimus cream 1%
干预措施: Pimecrolimus cream 1% (Drug)
结局指标
主要结局
• Decrease of the Dermatophot (a combination of a dermatoscope and a camera) score on skin deterioration and spider veins from baseline to end of the study
时间窗: 48 weeks
次要结局
- Skin metabolism by suction blisters.(48 weeks)
- • Epidermal thickness by optical coherence tomography at selected investigational centers(48 weeks)
- Skin thickness by ultrasound at selected investigational centers(48 weeks)
- Epidermal thickness by 3mm punch biopsies (optional)(48 weeks)
- Investigator's Global Assessment (IGA)(48 weeks)
研究者
研究点 (1)
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