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

Centro Studi Dermatologici S.r.l.45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Aging of Face and Hands Cicatrix

Interventions

Type I Bovine Collagen (HTIC)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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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: Subjects will not be enrolled in the study if any of the exclusion criteria listed below are met: 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.

Outcomes

Primary Outcomes

Measurement of the global aesthetic change between Visit 0 (Screening and Baseline) and Visit 5 (7 days) after the last HTIC injection

The aesthetic change will be assessed by the Investigator using a 5-point Global Aesthetic Improvement Scale (GAIS) by comparing the subject's photograph taken prior and after the treatment. (Scale values: from 1 to 5.) Lower scores indicate a better outcome (greater aesthetic improvement), while higher scores indicate a worse outcome (no improvement or worsening).

Time frame: Screening and Baseline visit (day 0) and Visit 5 ( 7 days after the last HTIC injection_Visit 4)

Secondary Outcomes

Clinical skin assessment together with photographic evaluation at Visit 0 and Visit 5, using the 7-point Modified Fitzpatrick Wrinkle Scale (MFWS).

Modified Fitzpatrick Wrinkle Scale (MFWS) Scale values: from 0 to 3 Lower scores indicate a better aesthetic outcome (fewer or less severe wrinkles), while higher scores reflect a worse outcome (more prominent or deeper wrinkles).

Time frame: Screening and Baseline visit (day 0) and visit 5 (7 days after the last HTIC injection_V4)

Self-assessment of the subject's satisfaction with the procedure using a Visual Analog Scale (VAS), ranging from 0 (very satisfied) to 10 (very dissatisfied), at Visit 5 compared to Visit 1

Visual Analog Scale (VAS) Scale range: 0 to 10, 0 (very satisfied) and 10 (very dissatisfied)

Time frame: Visit 5 (7 days from the last HTIC injection) and Visit 1(≤7 days from Screening & baseline visit_day 0)

Self-assessment of pain by the subject during the injection treatment at Visits 1, 2, 3, and 4, using a Visual Analog Scale (VAS) after each treatment

Time frame: At visit 1(≤7 days from Screening & Baseline visit_day 0), Visit 2 (7 days from V1), Visit 3(7 days from V2) and Visit 4 (7 days from V3)

Collection and evaluation of the rate of related adverse events (AEs) occurring during the study.

Time frame: at Screening & Baseline visit (day 0), Visit 1(≤7 days from V0), Visit 2 (7 days from V1), Visit 3 (7 days from V2), Visit 4 (7 days from V3) and Visit 5 (7 days from V4_the last HTIC injection)