Status:
COMPLETED
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
Lead Sponsor:
Centro Studi Dermatologici S.r.l.
Conditions:
Skin Aging of Face and Hands
Cicatrix
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 vo...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
Key Trial Info
Start Date :
January 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT07153393
Start Date
January 30 2025
End Date
May 27 2025
Last Update
September 4 2025
Active Locations (1)
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1
Azienda Ospedaliera Federico II
Napoli, Italy