Post-surgical Scars After the Use of CACIPLIQ20: A Randomized, Double-blind, Placebo -Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- differential appearance of the treated and untreated (placebo) scars at 24 weeks, using the global scar comparison scale assessed by a blinded adjudication committee composed of 3 experts.
研究概览
简要总结
Following surgical procedures or injury, cutaneous scars can develop due to production of collagen-rich connective tissue. These scars may be accompanied by redness, itching, pain, and restricted mobility of the skin. Typically, after a few weeks, the scar matures, becoming lighter and narrower, although full maturation of a scar may take up to 2 years. In some cases, however, cutaneous scars can be unsightly or can even become hyper- trophic or result in keloids.
Preventing pathological scarring is much easier than treating scars later and should be started as early as possible after the injury or surgery.
CACIPLIQ20® is a medical device used for the treatment of chronic skin ulcers, and contains a molecule belonging to the family of ReGeneraTing Agents (RGTA®). RGTA®s are biodegradable polymers that mimic the action of heparan sulfates found in the extracellular matrix of injured tissues. RGTA® accelerates tissue healing in various animal models, by stabilizing and protecting heparin-binding growth factors (HBGFs) and matrix proteins. In addition to its effects on hard-to-heal chronic wounds, CACIPLIQ20® was found to improve acute wound healing in pre-clinical models and in several case reports and controlled clinical studies. A first open label-controlled study showed that the topical application of RGTA® improved skin healing in mammoplasty patients and notably reduced oedema and pain in patients who had undergone centrofacial lift surgery compared to untreated patients. Results from this first study were confirmed in a double-blind placebo self-controlled trial conducted in two medical institutions in China involving 71 patients. The Chinese study showed that a single application of CACIPLIQ20® significantly improved scar healing quality at 14 days as well as scar symptoms including pain, swelling and exudate. The aim of the MATRISCAR study is to confirm the previous results in a double-blind, placebo-controlled randomized clinical trial.
详细描述
MATRISCAR is a double-blind, placebo-controlled, self-controlled, randomized clinical trial.
The main objective of this pivotal trial is to assess the superiority of a single application of CACIPLIQ20® over placebo on the clinical outcomes of the scars at 24 weeks. The primary endpoint will be the overall opinion on the appearance of the scar at 24 weeks, using the global scar comparison scale, centrally performed by an adjudication committee.
It is planned to include 50 female patients undergoing bilateral mammoplasty for breast hypertrophy, from 3 centers in France. Each subject's participation duration in the study is estimated to be 6 months. The enrolment period is estimated to be 8 to 10 months.
The targeted mammoplasties consist in the surgical reduction of both breasts volume, resulting in almost symmetrical scars. Surgical incisions of the bilateral breast reduction will be sutured according to local standard procedures. CACIPLIQ20® will be administered topically on the vertical and peri-areolar incisions of one breast for 5 minutes, after subcutaneous plans suture and just before final skin suture. The placebo will be administered in the same manner on the contralateral breast. As a result, each patient will receive both CACIPLIQ20® and placebo, thus reducing the interpersonal variability with a self-controlled design.
Standardized two-dimensional (2D) photographs of each scar will be collected at 4, 12 and 24 weeks by the investigator, as well as other clinical outcomes. The scars photographs of each patient at each visit will be placed side by side (i.e. 2 photos per patient/visit), for a centralized evaluation by an adjudication committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study is a double-blind study. Each product, CACIPLIQ20® or placebo, will be supplied in vials having the same appearance.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for bilateral breast reduction (>300 g by breast) using the conventional superior pedicle technique with inverted-T scars
- •Age between 18 and 85 years
- •Patients having received a full written and oral information about study conduct and objectives
- •Patients who can and are willing to be followed by the study investigator for the duration of the study
- •Patients benefiting from a valid health insurance or social security coverage
排除标准
- •Female patients who are pregnant, or lactating
- •Patients with, according to investigator's opinion, a very poor life expectancy
- •Patients intolerant to one of the study device components or to heparinoids
- •Any scar treatment other than the standard of care
- •Previous breast surgery
- •Current malignancy
研究组 & 干预措施
CACIPLIQ20®
CACIPLIQ20® is a medical device used for the treatment of chronic skin ulcers, and contains a molecule belonging to the family of ReGeneraTing Agents (RGTA®). CACIPLIQ20® will be administered topically on the vertical and peri-areolar incisions of one breast for 5 minutes, after subcutaneous plans suture and just before final skin suture.
干预措施: CACIPLIQ20® (Device)
placebo
The placebo solution (saline solution) will be administered on the contralateral side.
干预措施: Placebo (saline solution) (Drug)
结局指标
主要结局
differential appearance of the treated and untreated (placebo) scars at 24 weeks, using the global scar comparison scale assessed by a blinded adjudication committee composed of 3 experts.
时间窗: Up to 24 weeks (the primary endpoint will be judged at 24 weeks)
The global scar comparison scale (GSCS), ranging to -100 to +100, indicates by how much one of the scars has a better appearance than the contralateral scar. A positive score means that the CACIPLIQ side is improved and higher values mean higher improvement compared to the contralateral side.
次要结局
- Proportion, of scars improved by at least 30% at 12 weeks and 24 weeks based on the global scar comparison scale(up to 24 weeks (12 and 24 weeks))
- Mean patient POSAS (Patient and Observer Scar Assessment Scale) scale(At 24 weeks)
- Rate of adverse events (AEs)(up to 24 weeks)
- Mean observer POSAS (Patient and Observer Scar Assessment Scale) scale(At 24 weeks)
- Pain assessed by a Visual Analogue Scale (Pain VAS)(Up to 4 weeks)
- Rate of device deficiencies (DDs)(up to 24 weeks)
- Pruritus assessed by a Visual Analogue Scale (Pruritus VAS)(Up to 4 weeks)