NCT05528328: MATRISCAR

Post-surgical Scars After the Use of CACIPLIQ20

Status unknown Phase 3 Last updated 13 February 2024

What this trial tests

Phase 3 trial testing CACIPLIQ20® in Scars in 50 participants. Status unknown.

Timeline

21 March 2023

Primary endpoint
1 October 2024

1 October 2024

Quick facts

Lead sponsor	Organ, Tissue, Regeneration, Repair and Replacement
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	50
Start date	21 March 2023
Primary completion	1 October 2024
Estimated completion	1 October 2024
Sites	2 locations across France

Drugs / interventions tested

• CACIPLIQ20®
• Placebo (saline solution)

Conditions studied

• Scars — all drugs for Scars →

Sponsor

Organ, Tissue, Regeneration, Repair and Replacement

Who can join

Adults 18 to 85, female only, with Scars. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.