NCT06716398招募中不适用
A Randomized Investigator-blinded Comparative Study to Assess the Efficacy of the Cosmetic Care Product RV4133C - Formula JT2559 in Subjects With Facial Acne, During a 3-month-associated-treatment Phase Followed by a 3-month-maintenance Phase
Pierre Fabre Dermo Cosmetique2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Assessment of number of total acne lesions on the face
研究概览
简要总结
In this study, we are interested in the global benefit of the tested product as complementary care to a topical medical treatment during a 3 month-associated treatment phase followed by a 3 month-maintenance phase, compared to a light moisturizing cream, in teenagers and adults with acne. We also want to evaluate the tolerance of the tested product in association and in maintenance of the topical medical treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female aged between 14 and 24 years (included)
- •Subject with facial acne with score index severity IGA = 2 or 3, assessed on a scale ranged from 0 to
- •Subject for whom a prescription of 12 weeks of a reference topical medical treatment is required from the day of the inclusion visit, for mild to moderate face acne
排除标准
- •Criteria related to the disease:
- •Facial skin disease other than acne, skin abnormalities, or dermatological condition on the face liable to interfere with the study assessments
- •Acne conglobata, Acne fulminans, nodulocystic acne or acneiform eruptions, according to investigator's assessment
- •Other type of pigmentation disorder than acne-related PIH liable to interfere with the study assessments according to the investigator
- •Criteria related to treatments and/or products:
- •Topical or oral treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational products
结局指标
主要结局
Assessment of number of total acne lesions on the face
时间窗: Assessment after 24 weeks of use
Number of total acne lesions by counting according to the Lucky method performed by the investigator
次要结局
- Investigator's global assessment (IGA)(Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use)
- Acne lesions counting(Assessment at baseline and 1 week, 4 weeks, 12 weeks, 16 weeks and 24 weeks of use)
- Acne QoL questionnaire(Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use)
- Subject's Global change Assessment (SGA)(Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use)
- Post-Inflammatory Hyperpigmentation (PIH) lesions counting(Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use)
- Post-Inflammatory Erythema (PIE) lesions counting(Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use)
- Time to relapse(Assessment after 4 weeks and 12 weeks of use, without reference medical treatment)
- Subject's Global change Assessment (SGA) of post inflammatory lesions(Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use)
- Acne worsening/ relapse(Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use)
- Global tolerance assessed by the investigator on a 5-point scale(Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use)
- Compliance of the subjects to the product RV4133C(Through study completion, 6 months)
- Cosmetic satisfaction as regards to the use of the test product RV4133C by Cosmetic acceptability questionnaire assessed by the patient(Assessed after 4 weeks of use)
研究者
研究点 (2)
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