Scar Gel Product Family Clinical Investigation
PMCF Investigation to Compare the Clinical Performance/Benefit of Dermatix With Dermatix Ultra
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.
研究概览
研究类型
注册 (估计的)
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
The total number of subjects will be 75 per arm (150 total). However, to allow for potential dropouts and protocol deviations, the planned enrolment will be increased by approximately 10%, yielding a total of 84 per arm (168 total).
To ensure that both treatment groups include patients with (a) scars at risk of developing hypertrophic or keloid scars (i.e., recent scars) and (b) pre-existing hypertrophic or keloid scars (i.e., older scars), a stratified randomization procedure will be used. This approach will evenly distribute the proportion of older scars and recent scars between the two groups based on the estimated prevalence of pathological scars in the overall scar population.
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Recent Scar
Patients at risk of developing a hypertrophic or keloid scar, aged 3 years and older.
|
Patients will be supplied with two 15g tubes of Dermatix at Visit 1 - Baseline Visit with the clinician, which will be sufficient to last the duration of the study (6-months) when applied as instructed (i.e.
twice daily).
If for any reason the patient runs out of the investigational product, a contingency supply will be in place and patients will be supplied with an additional tube.
Patients will also be provided with the IFU of the supplied device and the clinician will provide instructions as to the application, frequency, and duration of use of the device (i.e.
applied topically to the scar, twice daily for 6 months/until final study visit).
Patients will be supplied with two 15g tubes of Dermatix Ultra at Visit 1 - Baseline Visit with the clinician, which will be sufficient to last the duration of the study (6-months) when applied as instructed (i.e.
twice daily).
If for any reason the patient runs out of the investigational product, a contingency supply will be in place and patients will be supplied with an additional tube.
Patients will also be provided with the IFU of the supplied device and the clinician will provide instructions as to the application, frequency, and duration of use of the device (i.e.
applied topically to the scar, twice daily for 6 months/until final study visit).
|
|
Older Scars
Patients with existing scars, aged 3 years and older,
|
Patients will be supplied with two 15g tubes of Dermatix at Visit 1 - Baseline Visit with the clinician, which will be sufficient to last the duration of the study (6-months) when applied as instructed (i.e.
twice daily).
If for any reason the patient runs out of the investigational product, a contingency supply will be in place and patients will be supplied with an additional tube.
Patients will also be provided with the IFU of the supplied device and the clinician will provide instructions as to the application, frequency, and duration of use of the device (i.e.
applied topically to the scar, twice daily for 6 months/until final study visit).
Patients will be supplied with two 15g tubes of Dermatix Ultra at Visit 1 - Baseline Visit with the clinician, which will be sufficient to last the duration of the study (6-months) when applied as instructed (i.e.
twice daily).
If for any reason the patient runs out of the investigational product, a contingency supply will be in place and patients will be supplied with an additional tube.
Patients will also be provided with the IFU of the supplied device and the clinician will provide instructions as to the application, frequency, and duration of use of the device (i.e.
applied topically to the scar, twice daily for 6 months/until final study visit).
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Vancouver Scar Scale (VSS)
大体时间：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.,
|
6 months of treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Satisfaction, Change from Baseline, Complications
大体时间：6 months of treatment
|
|
6 months of treatment
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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