NCT07153393

A Clinical Study Testing How Well the Medical Device HTIC (a Type of Animal-derived Collagen) Works in Treating Skin Problems, Such as Scars, Loss of Firmness, and Volume in Certain Areas of the Face and Body

A Single-Arm Study of HTIC (Heterologous Type I Collagen) Intradermal Injections for the Medical Treatment of Dermal Defects Due to Scarring, Hypotonia, and Hypotrophy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Centro Studi Dermatologici S.r.l. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to evaluate the efficacy of the experimental medical device HTIC, which contains Type I collagen of animal origin, in treating skin defects such as scars, loss of tone, and volume in certain areas of the face and body. HTIC is administered through an injection technique applied under the skin. The main research question is: "Is it possible to achieve clinical improvement of skin defects through the use of the experimental device HTIC?" Additionally, the study has the following secondary objectives: * To assess any discomfort experienced during administration; * To evaluate the subject's level of satisfaction following the entire treatment; * To assess the safety and tolerability of the experimental device HTIC. HTIC is a sterile powder composed solely of animal-derived collagen (heterologous bovine Type I collagen, allergen-free and compliant with current regulations), packaged in 10 ml glass vials. Each vial contains 100 mg of sterile bovine Type I collagen powder. The trial will be conducted at a single site in Italy, specifically at the Federico II University Hospital. A total of 45 subjects will participate in the study.

Conditions

• Skin Aging of Face and Hands
• Cicatrix
• Scars
• Atrophic Scar

Interventions

Type	Name	Description
DEVICE	Type I Bovine Collagen (HTIC)	HTIC is a sterile collagen powder (100 mg) contained in a glass vial, which is diluted by adding 5 ml of saline solution (0.9% sodium chloride solution) to obtain a suspension. This suspension will be prepared immediately before treatment. The procedure consists of performing a few microinjections of the product (0.1 ml per injection) into the dermis at intervals of approximately 2 cm, using a very fine needle (30G/32G, 4 mm) in the areas to be treated (face, neck, décolleté, and hands).

Timeline

• Start date: 2025-01-30
• Primary completion: 2025-05-27
• Completion: 2025-05-27
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: Italy