NCT01948869已完成不适用
An Investigator-blinded, Randomized, Monocentre, 3-arm, Pilot Trial to Compare the Efficacy and Safety of Two Topical Medical Devices in Patients With Mild to Moderate Atopic Dermatitis in an Intra-individual Comparison With Untreated Skin
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index
研究概览
简要总结
The study shall explore whether treatment of atopic dermatitis is equally effective with respect to a marketed medical device and a new medical device.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Caucasians aged between 18 and 60 years
- •Patients with mild to moderate AD (Atopic Dermatitis) presenting a scoring AD (SCORAD) rating below 50
- •Skin type I - IV according to Fitzpatrick
- •Acute AD symptoms on each assessment areas (local SCORAD ≥ 3 and </= 12) at Baseline
- •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, nonsteroidal anti-inflammatory drug [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
Phoenix II
Experimental
Application over 29 days twice daily
干预措施: Phoenix II (BAY81-2996) (Device)
Phoenix I
Active Comparator
Application over 29 days twice daily
干预措施: Phoenix I (BAY81-2996) (Device)
Untreated skin
No Intervention
Untreated skin areas of subjects will be observed over 29 days
结局指标
主要结局
Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index
时间窗: Up to 29 days
次要结局
- Intensity of pruritus by means of visual analogue scale (VAS)(Up to 29 days)
- Number of subjects with abnormal vital signs(Up to 10 weeks)
- Erythema by means of chromametry(Up to 29 days)
- Transepidermal water loss (TEWL) as a measure for skin barrier function(Up to 29 days)
- Skin hydration by means of corneometry(Up to 29 days)
- Number of patients with adverse events as a measure of safety and tolerability(Up to 10 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
不适用
Efficacy/Safety Study to Explore a New Topical Formulation in Atopic DermatitisDermatitis, AtopicNCT01691209Bayer
已完成
2 期
Sinecort Pilot Efficacy StudyAtopic DermatitisNCT00980135Bayer40
已完成
2 期
Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic DermatitisAtopic DermatitisNCT04504279Forte Biosciences, Inc.154
已完成
4 期
Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Pediatric Patients With Mild Atopic DermatitisDermatitis, AtopicNCT00667160Astellas Pharma Inc426
已完成
2 期
A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus HydrocortisoneDermatologic DiseaseNCT05607901Tanta University100