NCT00980135已完成2 期
An Investigator-blind, Randomized, Monocentre, 3-arm, Active Controlled Pilot Trial to Explore the Efficacy and Safety of a New Topical Medical Device in Patients With Mild Atopic Dermatitis in an Intra-individual Comparison With a Standard Therapy (1% Hydrocortisone Cream) and Untreated Skin.
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
- Bayer
- 入组人数
- 40
- 主要终点
- Efficacy rate versus comparator and untreated skin
研究概览
简要总结
The study shall prove whether treatment of atopic dermatitis is equally effective with Sinecort cream as compared to standard therapy (Hydrocortisone cream).
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
- Single (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
- •Male or female Caucasians aged between 18 and 65 years
- •Patients with mild AD presenting a scoring AD (SCORAD) rating between 3-25
- •Skin type I - IV according to Fitzpatrick
- •Acute AD symptoms on each assessment areas (local SCORAD >/=3 and <= 12)
- •Acute symptom of pruritus at Baseline
排除标准
- •Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator
- •Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment
- •Regular intake of antiphlogistic drugs (for example, NSAIDs)
- •Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)
- •UV-therapy or the use of solarium within 30 days before screening as well as during the trial
- •Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial
研究组 & 干预措施
Arm 1
Experimental
干预措施: Sinecort cream (Device)
Arm 2
Experimental
干预措施: Hydrocortison cream (Drug)
Arm 3
Other
干预措施: Untreated skin (Other)
结局指标
主要结局
Efficacy rate versus comparator and untreated skin
时间窗: After 29 days of twice daily applications
Local side effects on the skin
时间窗: 29 days
次要结局
- Skin hydration by means of corneometry at visit 2 through visit 6(after 29 days)
- Erythema by means of chromametry at Visit 2 through Visit 6(after 29 days)
- Local SCORAD as clinical assessment by means of the intensity items of the SCORAD index) at Visit 2 through Visit 6(after 29 days)
- Incidence and severity of Adverse Event(visit 2 (start of dosing period) till 6 weeks after end of treatment)
- Vital signs(visit1 and 6 weeks after end of treatment)
- Local side effects(visit 2 (start of dosing period) till 6 weeks after end of treatment)
- Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6(after 29 days)
- Intensity of pruritus at each day of the dosing period (day 1- day 29) as reported in the patients diary and at Visit 2 through Vist 6 by means of visual analogue scale (VAS)(after 29 days)
研究者
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