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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
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.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
No
Azienda Ospedaliera Federico II
Naples, Italy
Start Date
January 30, 2025
Primary Completion Date
May 27, 2025
Completion Date
May 27, 2025
Last Updated
September 4, 2025
45
ACTUAL participants
Type I Bovine Collagen (HTIC)
DEVICE
Lead Sponsor
Centro Studi Dermatologici S.r.l.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07368764