Clinical trial NCT05528328: Post-surgical Scars After the Use of CACIPLIQ20
Official title: Post-surgical Scars After the Use of CACIPLIQ20: A Randomized, Double-blind, Placebo -Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Scars
Keywords: mammoplasty
Lead sponsor: Organ, Tissue, Regeneration, Repair and Replacement
Sponsor class: INDUSTRY
First posted: 2022-09-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective double-blinded placebo self-controlled trial. 50 female patients undergoing bilateral mammoplasty for breast hypertrophy will be included.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.The treatment assignment for each breast will be randomized.The patient, investigator and adjudication committee will be blinded during the whole study, until all assessments have been performed.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

The treatment assignment for each breast will be randomized at treatment labelling. Treatments (active and placebo) will be dispensed in identical vials of 5 ml identified by treatment numbers and letters (R for the right breast, L for the left breast). The patient, investigator and adjudication committee will be blinded during the whole study, until all assessments have been performed. The independent monitor will ensure blinding is respected.

Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for bilateral breast reduction (\>300 g by breast) using the conventional superior pedicle technique with inverted-T scars
2. Age between 18 and 85 years
3. Patients having received a full written and oral information about study conduct and objectives
4. Patients who can and are willing to be followed by the study investigator for the duration of the study
5. Patients benefiting from a valid health insurance or social security coverage

Exclusion Criteria:

1. Female patients who are pregnant, or lactating
2. Patients with, according to investigator's opinion, a very poor life expectancy
3. Patients intolerant to one of the study device components or to heparinoids
4. Any scar treatment other than the standard of care
5. Previous breast surgery
6. Current malignancy

Primary outcomes:
measure: 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.
timeFrame: Up to 24 weeks (the primary endpoint will be judged at 24 weeks)
Secondary outcomes:
measure: Proportion, of scars improved by at least 30% at 12 weeks and 24 weeks based on the global scar comparison scale
timeFrame: up to 24 weeks (12 and 24 weeks)
measure: Pruritus assessed by a Visual Analogue Scale (Pruritus VAS)
timeFrame: Up to 4 weeks
measure: Mean observer POSAS (Patient and Observer Scar Assessment Scale) scale
timeFrame: At 24 weeks
measure: Mean patient POSAS (Patient and Observer Scar Assessment Scale) scale
timeFrame: At 24 weeks
measure: Pain assessed by a Visual Analogue Scale (Pain VAS)
timeFrame: Up to 4 weeks
measure: Rate of adverse events (AEs)
timeFrame: up to 24 weeks
measure: Rate of device deficiencies (DDs)
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
state: Bretagne
city: Paris
country: France
facility: Clinique Turin
state: Ile De France
Study officials:
affiliation: Clinique Turin
name: Gilbert Zakine
role: PRINCIPAL_INVESTIGATOR
References: