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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTIC - Adults 18-50, Fitzpatrick I-V, Mild to Moderate Skin Volume Loss | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Screening and Baseline visit (day 0) and Visit 5 ( 7 days after the last HTIC injection_Visit 4) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Screening and Baseline visit (day 0) and visit 5 (7 days after the last HTIC injection_V4) |
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Inclusion Criteria:
Exclusion Criteria:
Subjects will not be enrolled in the study if any of the exclusion criteria listed below are met:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Federico II | Naples | Italy |
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| 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) | 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 | 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. | 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) |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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