A Clinical Study Testing How Well the Medical Device HTIC (a Type of Animal-derived Collagen) Wor… (NCT07153393) | Clinical Trial Compass
CompletedNot Applicable
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
Italy45 participantsStarted 2025-01-30
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Exclusion criteria
. Pregnant or breastfeeding.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of the global aesthetic change between Visit 0 (Screening and Baseline) and Visit 5 (7 days) after the last HTIC injection
Timeframe: Screening and Baseline visit (day 0) and Visit 5 ( 7 days after the last HTIC injection_Visit 4)