NCT07194421已完成不适用
In-Use Tolerance & Efficacy Study Under Dermatological Control of Sunscreen in Adults With Atopic Dermatitis Skin
Pierre Fabre Dermo Cosmetique1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年10月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Global tolerance assessment by the investigator
研究概览
简要总结
This study evaluates a broad-spectrum SPF50+ sunscreen on 42 adults with Atopic Dermatitis, measuring skin tolerance and barrier function.
The study includes several visits as follow :
- Visit 1: Inclusion (Day 1)
- Visit 2: Intermediate Visit (Day 8)
- Visit 3: End of Study (Day 22)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phototype: from I to VI.
- •Sun Exposure: Adults anticipating at least 6 exposures of 2 hours each during the study.
- •Swimming Sessions: Subjects planning at least 4 swimming sessions, with a minimum of 50% intending to swim twice in the sea and twice in a pool.
- •Sensitive Skin: At least 50% of subjects report having sensitive skin.
- •Health Insurance: Must be registered with health social security or health insurance.
- •Informed Consent: Must have signed the written Informed Consent form (ICF) for study participation.
- •Personal Information: Must certify the accuracy of personal information provided to the Investigator.
- •Health Status: Considered a "healthy subject" by the Investigator (excluding SCORAD considerations).
- •Women of Childbearing Potential: Must agree to use an effective contraceptive method throughout the study and for at least 1 month prior to the inclusion visit.
- •Criteria Related to Skin Condition:
- •Atopic Dermatitis: Subject must present atopic dermatitis according to the U.K Working Party's Diagnostic Criteria for Atopic Dermatitis, with mild atopic dermatitis indicated by a SCORAD score of 15 to 25 (inclusive), determined by a dermatologist.
- •Reactivity: Must be reactive to external irritative factors such as chlorine, sand, salt, and sweat.
- •Non-Inclusion Criteria:
- •Criteria Related to Population:
- •Subjects who have participated in another clinical trial within the week before the inclusion visit, or for a longer period if deemed necessary by the Investigator.
- •Subjects currently participating or planning to participate in another clinical trial during the study, either in the same or a different investigation center.
- •Criteria Related to Subject's Health:
- •Subjects experiencing a flare of atopic dermatitis.
- •Pregnant or breastfeeding women (for women of childbearing potential).
- •Subjects with dermatological conditions that may interfere with study data or are considered hazardous by the Investigator (e.g., pityriasis versicolor, severe pigmentation disorders such as vitiligo, melasma, multiple lentigines, numerous or large congenital nevi).
- •Subjects with a personal medical history that may interfere with study data or is incompatible with study requirements (except if required by the Sponsor, e.g., atopic dermatitis).
排除标准
- 未提供
结局指标
主要结局
Global tolerance assessment by the investigator
时间窗: At the end of the study, after Last Patient Out, (after Day 22)
Global tolerance of the product is assessed on the "tolerance population" which includes all the subjects who applied investigational product at least once. This assessment allows for attribution of one of the 5 levels : excellent, very good, good, moderate, bad.
次要结局
- Evaluation Cosmetic Acceptability of the Sunscreen RV4620A - RP2552(Visit 3 (Day 22))
- Evaluation of Irritative Factors with Sunscreen RV4620A - RP2552(Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22))
- Evaluation of Transepidermal Water Loss with Sunscreen RV4620A - RP2552(Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22))
- Assessment of Skin pH with Sunscreen RV4620A - RP2552(Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22))
- Assessment of the Lipidic Index Evolution with Sunscreen RV4620A - RP2552(Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22))
研究者
研究点 (1)
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