NCT07341659进行中（未招募）不适用
A Multicentric, Randomized, Blinded, Comparative Study to Evaluate the Efficacy of the Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Treatment of Adult Subjects With Facial Acne.
Pierre Fabre Dermo Cosmetique5 个研究点 分布在 3 个国家目标入组 102 人开始时间: 2025年2月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
- 试验地点
- 5
- 主要终点
- Acne relapse rate
研究概览
简要总结
The aim of this study is to evaluate the efficacy of the RV3278B-OS0386 cosmetic product, compared to the control product in managing acne relapse during the 12-month maintenance phase follow-up after oral isotretinoin treatment in adult subjects with facial acne.
详细描述
This study is conducted as a multicentric, randomized, blinded, comparative study in Europe.
A total number of 102 subjects included and randomized in 2 parallel groups:
- Test group: twice daily application of the RV3278B-OS0386 cosmetic product on the whole face
- Control group: twice daily application of the RV3278B-OS0548 cosmetic product on the whole face
Subjects will be followed at regular intervals for up to 12 months or until the relapse of their acne on the face, whichever occurs first.
6 visits are planned:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female aged between 15 and 35 years included
- •Subject affiliated to a social security system or health insurance, or is a beneficiary if applicable
- •Subject who recently completed his/her first course of oral isotretinoin treatment
- •Subject with clear or almost clear facial acne
- •Non Inclusion criteria:
- •Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
- •Facial skin disease other than acne, skin abnormalities, or dermatological condition on the face liable to interfere with the study assessments
- •Severe or complicated cases of acne (ex: acne conglobate) according to investigator's assessment
- •Any acute, chronic or progressive disease or medical history liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- •Any surgery, chemical (e.g.: skin peel) or physical treatment on the face done within 12 months before the inclusion or planned during the study
- •Topical or systemic product or 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 product according to the investigator's assessment
排除标准
- 未提供
研究组 & 干预措施
Test Group
Experimental
This group will apply the test cosmetic product
干预措施: Test product RV3278BB-OS0386 (Other)
Control Group
Placebo Comparator
This group will apply the control cosmetic product
干预措施: Control product RV3278B-OS0548 (Other)
结局指标
主要结局
Acne relapse rate
时间窗: From Visit 1 (Day 1) to Visit 6 (Month 12 or early termination )
The acne relapse rate is defined as percentage of subjects experiencing acne relapse on the face according to the investigator
次要结局
- Acne severity by investigator(Visit 1 (Day 1),Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination).)
- Time to acne relapse(From Visit 1 (Day 1) to Visit 6 (Month 12 or early termination))
- Acne lesions count(Visit 1 (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination).)
- Post-inflammatory lesions count(Visit 1 (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination).)
- Acne severity by subject(Visit 1 (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination), and monthly at home.)
- Quality of life questionnaire(Visit 1 (Day 1), Visit 3 (Month 3) and Visit 6 (Month 12 or early termination).)
- Adverse events(From Visit 1 (Day 1) to Visit 6 ( Month 12 or early termination))
- Global Tolerance(Visit 3 (Month 3) and Visit 6 (Month 12 or early termination).)
- Acceptability Questionnaire assessment(Visit 4 (Month 6) and Visit 6 (Month 12 or early termination).)
- Standardized photographs of the subject's face for illustrative purpose only(Visit 1 (Day 1), Visit 4 (Month 6), and Visit 6 (Month 12 or early termination).)
- Transepidermal water loss(Visit 1 (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination).)
- Skin potential hydrogen(Visit 1 (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination).)
研究者
研究点 (5)
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