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

NCT ID: NCT07153393

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2025-05-27

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HTIC - Adults 18-50, Fitzpatrick I-V, Mild to Moderate Skin Volume Loss

In this arm, 45 subjects of both sexes, aged between 18 and 50 years, of Caucasian ethnicity with Fitzpatrick skin phototype ranging from I to V, will receive treatment with the experimental medical device HTIC. Participants will be selected based on the presence of skin defects characterized by mild to moderate volume loss due to acne scars, other skin lesions, or photoaging. Inclusion requires a minimum score of 2 according to the Modified Fitzpatrick Wrinkle Scale. The treatment involves subcutaneous administration of HTIC, consisting of injecting 0.1 ml per intradermal site at intervals of approximately 2 cm.

Group Type: EXPERIMENTAL

Type I Bovine Collagen (HTIC)

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adult subjects (age between 18-50 years).

2. Subjects in good health.

3. Subjects that presented skin atrophy from acne scarring, other injury, or photo-aging (from mild to moderate).

4. Subjects with a score at least 2 according to the Modified Fitzpatrick Wrinkle Scale (MFWS).

5. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Ethics Committee (EC).

Exclusion Criteria

1. Pregnant or breastfeeding.

2. Subjects that had undergone other medical invasive aesthetic treatments for the last 18 months before the enrolment.

3. Subjects with acne.

4. Subjects with seborrheic skin.

5. Subjects with normotonic, normoelastic, and normotrophic skin.

6. Subjects with autoimmune connective tissue disorders (connectivopathies).

7. Subjects with a tendency to develop hypertrophic or keloid scars.

8. Subjects undergoing immunosuppressive therapy.

9. Any cutaneous pathology of infectious, inflammatory, viral and vascular type affecting the treated area.

10. History of allergy or hypersensitivity to any component of the study devices.

11. Performing permanent filler in the past.

12. Use of any therapeutic agent for photoaging or skin rejuvenation within 15 days from the enrolment.

13. Smoking.

14. Wound healing disorders.

15. Participation in other clinical studies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Studi Dermatologici S.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Azienda Ospedaliera Federico II

Napoli, , Italy

Countries

Italy

Other Identifiers

HTIC-10-22

Identifier Type: -

Identifier Source: org_study_id