PMCF Investigation to Compare the Clinical Performance/Benefit of Dermatix With Dermatix Ultra
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Vancouver Scar Scale (VSS)
研究概览
简要总结
The purpose of this PMCF investigation is to determine whether there are differences between the two formulations (Dermatix and Dermatix Ultra) in improving keloid and hypertrophic scars clinical symptoms and in the overall scar perception (including scar appearance and treatment perception).
This PMCF investigation has been designed to address the conclusions of the latest CER [PDPROJ-4-CE-R] and the objectives. It has been chosen as an appropriate activity as it enables the collection of device-specific data on both device formulations and on the entire intended population. Moreover, the design of the PMCF investigation (single-center, parallel, open-label, two-arm, randomized controlled study) enables the direct comparison of the clinical performance/benefit between the two formulations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >3 years.
- •Patients with keloids and hypertrophic scars (such as those resulting from general surgical procedures, trauma wounds, and burns), i.e., older scars.
- •Patients at risk of developing keloids and hypertrophic scars, i.e., recent scars.
排除标准
- •Patients with unhealed and/or open wounds.
- •Patients with allergies to any of the ingredients.
- •Pregnant or breastfeeding women.
- •Patients using other topical skin treatments on/around the scar area.
结局指标
主要结局
Vancouver Scar Scale (VSS)
时间窗: 6 months of treatment
Comparison of clinical symptoms and scar appearance between Dermatix and Dermatix Ultra (between the two study arms) using the Vancouver Scar Scale (VSS), i.e., * scar pigmentation * scar vascularity * scar pliability/elasticity * scar height * scar itchiness * scar pain
次要结局
- Satisfaction, Change from Baseline, Complications(6 months of treatment)