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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT05808205
Eligibility Criteria:
Inclusion Criteria:
* Patient Informed consent form (ICF) signed;
* M \& F Aged ≥ 18 years at the time of the signature of ICF;
* Patients with medium and deep facial sagging, facial volume defects and/or lips volume and contours defects (nasolabial folds, wrinkles around the mouth facial and acne scars, glabellar wrinkles, wrinkles on the forehead, areas of the face which require enrichment of the facial tissue - cheeks, chin, cheekbones, lips - with temporary volumetric increase through growth of the soft tissues).
* Willing to follow all study procedures, including attending all site visits, tests and examinations;
* Willing to follow indications to not be exposed to make-up, excessive heat (sun, UV tanning sessions or laser) or intense cold after the treatment and until the complete absorption of swelling and reddening.
Exclusion Criteria:
* Other - different - clinical conditions of skin layers;
* Sagging and volume defects in other parts of the body different from face;
* Infective or inflammatory processes near the area of intervention;
* Presence of tendon, bone or muscular implants near the area of intervention;
* Ongoing cutaneous allergies;
* Serious and Chronical pathological skin conditions (i.e. rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy;
* Known hypersensitivity to cheloids;
* Allergy to device components;
* Immune system illnesses;
* Diabetes mellitus or uncontrolled systemic diseases;
* Problems with coagulation or anti-coagulating therapies in progress;
* Current treatment with substances which act on blood fluidity (eg. Aspirin, NSAID, Vitamin E);
* History of permanent filler treatment;
* Known drug and/or alcohol abuse;
* Mental incapacity that precludes adequate understanding or cooperation;
* Participation in another investigational study;
* Pregnancy Status (as per ALIAXIN products leaflet).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05808205
Study Brief:
Protocol Section:
NCT05808205