NCT06800755已完成不适用
Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population With Stable Mild Plaque Psoriasis, Dry Skin and Pruritus
Pierre Fabre Dermo Cosmetique2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pruritus intensity assessment
研究概览
简要总结
The product RL3020-DP0364 developed by Pierre Fabre Laboratories moisturizes durably and repairs dry or atopic skin, especially in the case of certain dermatoses (atopic dermatitis, ichthyosis, etc ...) and erythema induced by radiotherapy. Its unique formula treats the symptoms of dry skin by creating a protective film that prevents dehydration and helps protect the skin from external aggressions.
Through this study, the efficacy of this medical device will be evaluated specifically in subjects presenting stable psoriasis, dry skin and pruritus with an application on the whole body (excluding the head).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with stable mild plaque psoriasis covering ≤ 10% BSA (Body Surface Area; excluding the head*)
- •Subject whose plaque psoriasis has been diagnosed for at least 6 months before the inclusion visit
- •Subject with dry skin according to the investigator assessment
- •Subject with a pruritus intensity (on average over the previous 24 hours) ≥ 3 on a Numerical Rating Scale (NRS) between 0 and 10 (with 0 = no pruritus and 10 = worst imaginable pruritus) on the body*
- •the head is not included in the evaluated area
排除标准
- •Criteria related to the disease:
- •Subject with erythrodermic psoriasis, pustular psoriasis
- •Subject with palmoplantar keratoderma
- •Subject with any other aetiology of pruritus, not related to plaque psoriasis
- •Subject with history of allergy or intolerance to any of the tested product ingredients
- •Subject having any other dermatologic condition than psoriasis, or characteristics (like tattoo, wound…) on body liable to interfere with the study assessments
- •Subject having an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- •Criteria related to treatments and/or products:
- •Biotherapy treatment in the 6 months prior to the inclusion visit or ongoing or planned to be started during the study
- •Other systemic treatment for psoriasis (acitretin, cyclosporine, methotrexate, apremilast...) in the 3 months prior to the inclusion visit or ongoing or planned to be started during the study
- •Phototherapy treatment in the 4 weeks prior to the inclusion visit or ongoing or planned to be started during the study
- •Any other systemic treatment incompatible with the study or liable to interfere with the study assessments according to the investigator, in the weeks prior to the inclusion visit, ongoing or planned to be started during the study
- •Topical treatment for psoriasis (corticosteroid, vitamin D analogs…) applied on the body* in the 4 weeks prior to the inclusion visit or ongoing or planned to be started during the study
- •Topical product (including any moisturizer, emollient, keratolytic …) applied on the body* in the 7 days prior to the inclusion visit or ongoing or planned to be started during the study
- •Any product applied on the body* before the visit, the day of inclusion visit
- •Any other topical treatment or product applied on the body* incompatible with the study or liable to interfere with the study assessments according to the investigator, in the weeks prior to the inclusion visit, ongoing or planned to be started during the study
- •the head is not included in the evaluated area
研究组 & 干预措施
Adults with stable mild plaque psoriasis, dry skin and pruritus
Experimental
Device: Dexeryl (RL3020-DP0364) Tested product is applied twice a day. The maximum duration of application is 30 days.
干预措施: Dexeryl (RL3020-DP0364) (Device)
结局指标
主要结局
Pruritus intensity assessment
时间窗: 29±2 days
The pruritus intensity on the whole body (head excluded) (on average over the previous 24 hours) will be assessed by the subject at Visit 1 (Day 1-before product application) and at Visit 3 (Day 29(±2)) according to the following \[0-10\] Numerical Rating Scale
次要结局
- Average pruritus intensity assessment (previous 24hours)(Day 1, Day 8, Day 14±2, Day 29±2)
- Average pruritus intensity assessment (previous 7 days)(Day 1, Day 8, Day 14±2, Day 29±2)
- Worst pruritus intensity assessment (previous 7 days)(Day 1, Day 8, Day 14±2, Day 29±2)
- Pruritus severity and impact on quality-of-life assessment(Day 1, Day 14±2, Day 29±2)
- Pruritus characteristics assessment(Day 1, Day 29±2)
- mPASI assessment(Day 1, Day 14±2, Day 29±2)
- Xerosis intensity assessment(Day 1, Day 14±2, Day 29±2)
- Tolerance assessment(Day 29±2)
- Acceptability questionnaire assessment(Day 29±2)
- Illustrative photographs assessment(Day 1, Day 14±2, Day 29±2)
研究者
研究点 (2)
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