Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel Versus Benchmark in Preventing Hypertrophic Scars and Improving Scar Appearance
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Assessment of clinical and perceived efficacy
研究概览
简要总结
Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use, comparing it to a benchmark for preventing hypertrophic scars and improving appearance, hydration and pigmentation.
详细描述
Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use. Comparison of the efficacy of the investigational product with the benchmark product in preventing hypertrophic scars and improving scar appearance, as well as analyzing parameters such as skin hydration, pruritus, discomfort, and normalization of scar pigmentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants of both sexes aged between 18 and 70 years;
- •Participants with recent scars (<30 days);
- •Participants with phototypes III to VI according to the Fitzpatrick scale;
- •Agree to follow the trial procedures and attend the center on the days and times determined for evaluations;
- •Understand, agree to and sign the free and informed consent form.
- •Types of scars: cesarean section, breast implant or blunt cut injury.
排除标准
- •Pregnancy or risk of pregnancy;
- •History of atopic or allergic reactions to cosmetic products;
- •Participants who are using topical antibiotics or other skin products on the same area being evaluated;
- •Immunosuppression due to drugs or active diseases;
- •Decompensated endocrine diseases;
- •Relevant clinical history or current evidence of alcohol or other drug abuse;
- •Known history or suspected intolerance to products in the same category;
- •Intense sun exposure up to 15 days before the evaluation;
- •Patients who are using topical antibiotics or other skin products on the same area being evaluated.
研究组 & 干预措施
Participants of both sexes, 18 - 70 y
Participants of both sexes, 18 - 70 y, who have recent scars.
干预措施: Scar gel comparator (Device)
Exp.: Participants of both sexes, 18 - 70 y
Participants of both sexes, 18 - 70 y, with recent scars
干预措施: Scar gel (Device)
结局指标
主要结局
Assessment of clinical and perceived efficacy
时间窗: 90 days
Evaluate the prevention of hypertrophic scars after 90 days of continuous use of the investigational product. The dermatologist will perform assessments of the clinical parameters using the POSAS scale.
次要结局
- Perceived efficacy(90 days)