NCT05575882招募中不适用
Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Change of acute flares of eczema in patients with chronic atopic dermatitis (AD)
研究概览
简要总结
Multicentric, double blind, randomized, comparative study with two parallel group: study group vs placebo group. 5 visits: inclusion visit [day (D) 0] and 4 follow-up visits (D30, D60, D90, and D120).
详细描述
This is a prospective, double blind, multicentric and comparative study including 5 visits (on D0 which corresponds to inclusion visit, D30, D60, D90, and D120). It will take place from June 2024 to June 2025 in Argentina (CIREC LATAM, Buenos Aires) and India (CIDP, New Dheli). This study will include 100 patients (50 in India and 50 in Argentina) who will be followed up for 120 days (± 3 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
white plastic bottles and automatized randomization in eCRF.
入排标准
- 年龄范围
- 6 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General criteria:
- •Healthy subject (except AD and other atopic diseases - allergic rhinitis, conjunctivitis, and asthma). The subject can keep its usual treatment (antihistamines, inhaled corticosteroids, and antileukotriene treatment) during the study if applicable. Written informed consent from the subject's parent(s)/legal representative(s) and children over 8 years old (specific Argentina) and over 12 years old (specific Singapore). Subject accepting to continue the normal conditions of hygiene and sunscreen (if applicable). Subject, parents/legal representative(s) willing to adhere to the study protocol and procedures.
- •Specific criteria:
- •Sex: male or female. Age: from 6 months to 15 years. Subject having on average one flare-up per month during the four months preceding the study, including the one observed on the inclusion visit D
- •Subject having EASI value from 7.1 - 21 on D0 (moderate AD). Subject having one atopic eruption on the inclusion visit which the dermatologist will prescribe topical corticosteroids or calcineurin's inhibitors (pimecrolimus and/or tacrolimus).
排除标准
- •Subject presenting cutaneous pathology in the studied zone other than AD (according to the investigator's appreciation, i.e., acne, psoriasis). Subject using systemic treatment, including oral steroids and oral immunosuppressants e.g., ciclosporin during the previous weeks liable to interfere with the assessment of the cutaneous tolerance of the study product or placebo (according to the investigator's appreciation). Subject using skin-moisturizing products from inclusion (D0) other than the study product or placebo. Subject who had systemic therapy with immune-suppressive drugs and antibiotics within the last 14 days before the beginning of the study Subject having serious illness that might require regular systemic medication (e.g., insulin-dependent diabetes, cancer) or conditions that exclude a participation or might influence the study evaluation. Subject with documented allergies to the study product or placebo ingredients. Subject enrolled in another clinical study during the study period. Parent(s)/legal representative(s) considered by the investigator to be likely not compliant to the protocol.
结局指标
主要结局
Change of acute flares of eczema in patients with chronic atopic dermatitis (AD)
时间窗: 4 months
Clinical evaluation by dermatologist on each visit and daily log statements by the parents.
次要结局
- Change on itching(0-30, 31-60, 61-90 and 91-120 days of treatment)
- Change of Atopic Dermatitis using the Eczema Area and Severity Index (EASI)(0-30, 31-60, 61-90 and 91-120 days of treatment)
- Change of stratum corneum (SC) hydration.(0-30, 31-60, 61-90 and 91-120 days of treatment)
- Change on the trans-epidermal water loss (TEWL).(0-30, 31-60, 61-90 and 91-120 days of treatment)
- Change on the pH.(0-30, 31-60, 61-90 and 91-120 days of treatment)
- Change on quality of life.(0-30, 31-60, 61-90 and 91-120 days of treatment)
- Subjective appreciation of efficacy and acceptability by the parent(s)/legal representative(s) and/or their child.(120 days)
- Change of Atopic Dermatitis using the Investigator's Global Assessment (IGA)(0-30, 31-60, 61-90 and 91-120 days of treatment)
- Change on sleep disturbances.(0-30, 31-60, 61-90 and 91-120 days of treatment)
- Tolerance of the study product or placebo(0-30, 31-60, 61-90 and 91-120 days of treatment)
研究者
研究点 (6)
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