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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

NCT07153393 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-09-04

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Centro Studi Dermatologici S.r.l.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-30
Primary Completion
2025-05-27
Completion
2025-05-27

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07153393 on ClinicalTrials.gov