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

August 29, 2025 updated by: Centro Studi Dermatologici S.r.l.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy
        • Azienda Ospedaliera Federico II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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
Time Frame: Screening and Baseline visit (day 0) and Visit 5 ( 7 days after the last HTIC injection_Visit 4)

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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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).
Time Frame: Screening and Baseline visit (day 0) and visit 5 (7 days after the last HTIC injection_V4)
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)
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
Time Frame: Visit 5 (7 days from the last HTIC injection) and Visit 1(≤7 days from Screening & baseline visit_day 0)
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
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)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centro Studi Dermatologici S.r.l.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HTIC-10-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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