Skin Aging of Face and HandsNCT07153393
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
A study testing Type I Bovine Collagen (HTIC) in people with Skin Aging of Face and Hands and Cicatrix, run by Centro Studi Dermatologici S.r.l. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Skin Aging of Face and Hands, Cicatrix, Scars
- What is being tested?
- Type I Bovine Collagen (HTIC)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jan 2025to 27 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult subjects (age between 18-50 years).
- Subjects in good health.
- Subjects that presented skin atrophy from acne scarring, other injury, or photo-aging (from mild to moderate).
- Subjects with a score at least 2 according to the Modified Fitzpatrick Wrinkle Scale (MFWS).
- 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).
Who cannot join
- Subjects will not be enrolled in the study if any of the exclusion criteria listed below are met:
- Pregnant or breastfeeding.
- Subjects that had undergone other medical invasive aesthetic treatments for the last 18 months before the enrolment.
- Subjects with acne.
- Subjects with seborrheic skin.
- Subjects with normotonic, normoelastic, and normotrophic skin.
Show all 16Show fewer
- Subjects with autoimmune connective tissue disorders (connectivopathies).
- Subjects with a tendency to develop hypertrophic or keloid scars.
- Subjects undergoing immunosuppressive therapy.
- Any cutaneous pathology of infectious, inflammatory, viral and vascular type affecting the treated area.
- History of allergy or hypersensitivity to any component of the study devices.
- Performing permanent filler in the past.
- Use of any therapeutic agent for photoaging or skin rejuvenation within 15 days from the enrolment.
- Smoking.
- Wound healing disorders.
- Participation in other clinical studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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
- Being tested
- Type I Bovine Collagen (HTIC)
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Type I Bovine Collagen (HTIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Screening and Baseline visit (day 0) and Visit 5 ( 7 days after the last HTIC injection_Visit 4)
Secondary outcomes (4)
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).
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start30 Jan 2025
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Aging of Face and HandsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Studi Dermatologici S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153393
- Sponsor's protocol ID
- HTIC-10-22
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07153393
- Acronym / sponsor ID
- HTIC-10-22
- Conditions
- Skin Aging of Face and Hands, Cicatrix, Scars, Atrophic Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centro Studi Dermatologici S.r.l.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HTIC - Adults 18-50, Fitzpatrick I-V, Mild to Moderate Skin Volume Loss | Experimental | Device: Type I Bovine Collagen (HTIC)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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult subjects (age between 18-50 years).
- Subjects in good health.
- Subjects that presented skin atrophy from acne scarring, other injury, or photo-aging (from mild to moderate).
- Subjects with a score at least 2 according to the Modified Fitzpatrick Wrinkle Scale (MFWS).
- 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).
Key exclusion criteria (16 listed)
- Subjects will not be enrolled in the study if any of the exclusion criteria listed below are met:
- Pregnant or breastfeeding.
- Subjects that had undergone other medical invasive aesthetic treatments for the last 18 months before the enrolment.
- Subjects with acne.
- Subjects with seborrheic skin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | HTIC - Adults 18-50, Fitzpatrick I-V, Mild to Moderate Skin Volume Loss |
Primary outcome
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).
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).
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type I Bovine Collagen (HTIC) in people with Skin Aging of Face and Hands and Cicatrix, run by Centro Studi Dermatologici S.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.