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 range18 Years – 50 Years
SexALL
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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.
✕. 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.
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)