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:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT07151859
Eligibility Criteria:
Inclusion Criteria:
1. Subject Informed consent form (ICF) signed;
2. Female and male Subjects aged 18-70 years;
3. Subjects desiring improvement of skin hydration in maximum 1 area of the face or desiring improvement of skin hydration of neck or décolleté.
4. Healthy skin;
5. Willingness to discontinue all dermatological treatment and procedures during the study;
6. Willingness to follow all study procedures, including attending all site visits, tests and examinations;
7. Agreeing to present at each study visit without face/neck/décolleté cosmetics;
8. Accepting to not change their habits regarding food, physical activity, face/neck/décolleté cosmetics and cleansing products;
9. Willingness to follow indications to avoid make-up in the 12 hours following the injection treatment and to avoid any prolonged exposure to the sun, UV rays and temperatures below 0°C, as well as any sauna or hammam sessions at least until the wheals have been fully reabsorbed;
10. Skin phototype I-IV according to Fitzpatrick's classification.
Exclusion Criteria:
1. Other - different - clinical conditions of the skin (i.e. rosacea, psoriasis, vitiligo, active eczema, severe scleroderma, severe acne and diagnosticated cancer with/without ongoing antitumor therapy);
2. Infectious or inflammatory processes near the area of intervention;
3. Presence of cutaneous disease on the tested area, as malformations and recurrent facial/labial herpes;
4. Presence of tendon, bone or muscular implants near the area of intervention;
5. Ongoing cutaneous allergies;
6. Allergy or contraindications to device components;
7. Concomitant intake of anticoagulant or antiplatelet medications;
8. Subjects who have not followed a washout period of 2 weeks from topical corticosteroids, antibiotics, benzoyl-peroxide, azelaic acid, hydroxy acids, topical retinoids;
9. Immune system illnesses/disease;
10. Uncontrolled diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder);
11. Treatment with substances which act on blood fluidity (eg. Aspirin, NSAIDs, Vitamin E), or drugs able to influence the test results in the investigator opinion, within 5 days prior to study inclusion;
12. Known drug and/or alcohol abuse;
13. Mental incapacity that precludes adequate understanding or cooperation;
14. Any previous permanent and non-permanent cutaneous treatment for aesthetic correction (biomaterial implant, lifting, laser, botulinum toxin injections, chemical peeling, fillers) of the treated area within 6 months prior to study inclusion;
15. Pregnancy or breastfeeding;
16. Participation in another investigational study within 1 month prior to study inclusion.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07151859
Study Brief:
Protocol Section:
NCT07151859