Exploratory Study to Evaluate the Efficacy of the Cosmetic Product RV3895A on Re-epidermised Scars Following Burns and Surgical Stitches in Adults, Adolescents and Children Over a 6-month Follow-up Period
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Physical aspect of scar(s) compared to normal skin by the investigator
研究概览
简要总结
This study is exploratory, non-comparative and open-label, conducted in France. It aims to provide insights into the effectiveness and safety of RV3895A - RY1774, potentially benefiting participants by improving scar appearance and quality of life.The aim of this study is to evaluate the efficacy of the cosmetic product RV3895A - RY1774 on re-epidermised scars of the face and body following burns and surgical stitches in adults, adolescents and children over a 6-month follow-up period.
Patients are divided into 2 groups:
- Group 1: adults with:
- Subgroup 1A: adults with post-burn scar(s)
- Subgroup 1C: adults with post-surgical scar(s) requiring stitches to be inserted and removed if applicable (in the case of non-absorbable stitches).
- Group 2: children and/or adolescents including children aged 2 to 7 years inclusive with:
- Subgroup 2A: children/adolescents with post-burn scar(s)
The study consists of 4 visits:
Visit 1: Inclusion (Day 1), Visit 2: Intermediate visit (Day 22), Visit 3: Intermediate visit (Day 85), Visit 4: End-of-study visit (planned or anticipated) (Day 169 )
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
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Physical aspect of scar(s) compared to normal skin by the investigator
时间窗: Day 1, Day 22, Day 85, and Day 169
The investigator assessed the physical appearance of the studied scar(s) in comparison to normal skin using the "POSAS Observer Scale" (Patient and Observer Scar Assessment Scale)
Physical and functional aspect of scar(s) by the subject
时间窗: Day 1, Day 22, Day 85, and Day 169, and monthly at home between Visit 2 and Visit4
Subjects who were of age to complete the assessment evaluated the physical appearance in comparison to normal skin and the functional appearance of the studied scar(s) using the "POSAS Patient Scale"
Soothing effect
时间窗: at Day 1 (before and after product application), Day 22, Day 85, and Day 169, and monthly at home between Visit 2 and Visit 4.
The subject/parent(s) or legal guardian(s) evaluated the soothing effect using a Numerical Rating Scale (NRS) to assess discomfort over the past 3 days (except for the evaluation at Day 1 after application) from 0 (no discomfort) to 10 (severe discomfort)
Inflammatory aspect of scar
时间窗: at Day 1, Day 22, Day 85, and Day 169
The investigator evaluated the inflammatory aspect of the scar using the vitropression test
Evolution of scar aspect compared to Day 1
时间窗: at Day 22, Day 85, and Day 169
The investigator assessed the evolution of the scar's appearance compared to D1 based on all parameters evaluated in the study using a dynamic Investigator's Global Assessment (IGA) scale ranging from -1 (worsening), 0 (no change), 1 (slight improvement), 2 (clear improvement), 3 (very clear improvement)
Overall satisfaction with Test product (Investigator's assessment)
时间窗: at Day 22, Day 85, and Day 169
The investigator assessed overall satisfaction with the product's impact on scar appearance based on usual practice and study parameters using an NRS from 0 (not at all satisfied) to 10 (very satisfied)
Overall satisfaction with Test product (Subject/Parent/Guardian assessment)
时间窗: at Day 22, Day 85, and Day 169
The subject/parent(s) or legal guardian(s) assessed overall satisfaction with the product's impact on scar appearance using an NRS from 0 (not at all satisfied) to 10 (very satisfied)
Erythema quantification
时间窗: at Day 1, Day 22, Day 85, and Day 169
Erythema was quantified using chromametry through spectrocolorimetric parameters
Dermatology Life Quality Index (DLQI)
时间窗: at Day 1, Day 22, Day 85, and Day 169 and monthly at home between Visit 2 and Visit 4
Quality of life was assessed by subjects of appropriate age using the Dermatology Life Quality Index (DLQI) questionnaire
Specific impact of burns on quality of life
时间窗: at Day 1, Day 22, Day 85, and Day 169
For subgroup 1a (Burns) only : evaluated by subjects using the "body image" and "heat sensitivity" subdomains of the Burn Specific Health Scale-Brief (BSHS-B)
Visual aspect of the scar through illustrative photographs
时间窗: at Day 1, Day 22, Day 85, and Day 169.
The quantity of product used calculated by weighing the tubes
时间窗: Between Day 1 and Day 169
Subjective cosmetic acceptability of the product
时间窗: at Day 22, Day 85, and Day 169
The subjective cosmetic acceptability of the product was evaluated by the subject/parent(s) or legal guardian(s) using a questionnaire
Recording of adverse events
时间窗: at Day 1 (first application of the product on site), Day 22, Day 85, and Day 169
At each visit, the occurrence of adverse events since the last visit was determined based on spontaneous reports from the subject/parent(s) or legal guardian(s), non-subjective questioning, and clinical evaluations performed by the investigator. All adverse events were recorded in the Case Report Form (CRF)
Overall tolerance assessed by the investigator
时间窗: at Day 22, Day 85, and Day 169
Overall tolerance was assessed by the investigator considering all individual adverse events and their characteristics, as well as past experience with similar products, using a 5-point scale (Excellent, Very Good, Good, Moderate, Poor)
Compliance
时间窗: Duration of the study, from Day 1 to Day 169
The subject was to record in their subject diary the applications of the study product, as well as any omissions and changes in frequency
次要结局
未报告次要终点