Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 1:09 AM
NCT ID:
NCT07153393
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07153393
Study Brief:
Protocol Section:
NCT07153393