Multicenter, Two-phase Exploratory Clinical Trial to Examine Efficacy and Safety After Open-label Topical Administration of a Medical Device (Bepanthen Itch Relief Cream) for Treatment of Acute Flare-ups Followed by Topical Administration of a New Cosmetic Bepanthen Product or a Cosmetic Comparator in a Parallel-group, Randomized, Investigator-blinded Care Phase for Skin Care in the Remission Phase in Infants With Mild Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 136
- 试验地点
- 14
- 主要终点
- Efficacy: Quality of Life according to questionnaire
研究概览
简要总结
- Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch Relief Cream).
- Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially available cosmetic product
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written parents' informed consent to have their child participate in the study and attend the study procedures and processes as outlined in the protocol
- •Male or female babies/children aged between 1 month and 4 years
- •Mild AD presenting a maximum SCORAD of 25 (at Screening and Baseline)
- •Acute flare-up phase
- •Local SCORAD ≥ 5 on the target area (at Screening and Baseline)
- •Skin type I - IV according to Fitzpatrick
排除标准
- •Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator
- •Known allergies to any of the ingredients of the IMPs
- •Any other adjuvant therapy for AD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study
- •Any use of another topical emollient or other established treatment for AD during Phase 1 (cure phase) and Phase 2 (care phase) at the site of flares (AD lesions). Exception are usual hygienic products in the nappy area
研究组 & 干预措施
Phase 1 (Cure phase)
Efficacy and safety of the medical device Bepanthen Itch Relief Cream in children´s mild AD (responders will enter study phase 2)
干预措施: Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543) (Device)
Phase 2 (Care phase) / Arm 1
Efficacy and safety of the new cosmetic Bepanthen test product in maintaining healthy skin in the remission phase after cure of children´s mild AD
干预措施: New cosmetic Bepanthen product: Pumpkin (BAY207543) (Other)
Phase 2 (Care phase) / Arm 2
Efficacy and safety of Stelatopia (cosmetic comparator) in maintaining healthy skin in the remission phase after cure of children´s mild AD
干预措施: Stelatopia (cosmetic comparator) (Other)
结局指标
主要结局
Efficacy: Quality of Life according to questionnaire
时间窗: up to 3 months
Efficacy: Intensity of pruritus according to diary
时间窗: up to 3 months
Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)
时间窗: up to 3 months
Efficacy: SCORAD with included parameters "extent of disease/area affected" [%] as well as average intensity of pruritus and sleeplessness
时间窗: up to 3 months
Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness
时间窗: up to 3 months
Efficacy: Time to flare-up (Phase 2, only)
时间窗: up to 3 months
Efficacy: Intensity of sleeplessness according to diary
时间窗: up to 3 months
Efficacy: Percent of subjects with flare-up (Phase 2, only)
时间窗: up to 3 months
次要结局
- Safety: Number of adverse events (AE)(up to 3 months)
- Safety: vital signs(up to 3 months)
- Safety: physical examination(up to 3 months)
- Safety: Local tolerability (by AE assessment)(up to 3 months)