Post-surgical Scars After the Use of CACIPLIQ20

NCT05528328 | Recruiting Phase 3

• 1 other identifier: 2022-A00833-40
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Scars

Keywords

mammoplasty

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Up to 24 weeks (the primary endpoint will be judged at 24 weeks)

Secondary Outcomes (7)

• 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)

• Pruritus assessed by a Visual Analogue Scale (Pruritus VAS)

  Up to 4 weeks

• Mean observer POSAS (Patient and Observer Scar Assessment Scale) scale

  At 24 weeks

• Mean patient POSAS (Patient and Observer Scar Assessment Scale) scale

  At 24 weeks

• Pain assessed by a Visual Analogue Scale (Pain VAS)

  Up to 4 weeks

Study Arms (2)

CACIPLIQ20®

ACTIVE COMPARATOR

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.

Device: CACIPLIQ20®

placebo

PLACEBO COMPARATOR

The placebo solution (saline solution) will be administered on the contralateral side.

Drug: Placebo (saline solution)

Interventions

CACIPLIQ20® DEVICE

CACIPLIQ20®

CACIPLIQ20®

Placebo (saline solution) DRUG

Placebo (saline solution) administered in identic al vials

placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organ, Tissue, Regeneration, Repair and Replacement: lead

Study Sites (2)

CHU Brest

Brest, Brittany Region, 29200, France

RECRUITING

Clinique Turin

Paris, Île-de-France Region, 75000, France

RECRUITING

MeSH Terms

Conditions

Cicatrix

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Gilbert Zakine

  Clinique Turin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederic Sedel, MD, PhD

CONTACT

+33 (0)1 83627895; frederic.sedel@otr3.com

Martin Inizan, Ingener

CONTACT

martin.inizan@otr3.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is a double-blind study. Each product, CACIPLIQ20® or placebo, will be supplied in vials having the same appearance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 6, 2022
• Study Start: March 21, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

FR (2)