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 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT06454994
Eligibility Criteria:
Inclusion Criteria:
* BMI comprised between 18.5 and 30
* No ongoing or planned diet.
* Group 1: requiring an aesthetic treatment of upper face with resorbable threads.
* Group 2: Subject requiring an aesthetic treatment of mid-face and lower-face with resorbable threads
* Subject with dense and not too thin skin.
Exclusion Criteria:
* Pregnant or nursing woman or planning a pregnancy during the study;
* Suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study result and/or subject safety, especially cardiac disorder, non-controlled high blood pressure, diabetes, panic disorders, depression, active auto-immune disease, cold, high fever,…
* Suffering from malnutrition.
* Acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events.
* Wound healing disorder or with a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
* History of precancerous lesions/skin malignancies.
* Active skin disease within 6 months of study entry.
* Scars, rosacea, herpes, acne, blotches or other pathology in the face, at the investigator appreciation.
* Predisposed to keloidosis or hypertrophic scarring.
* Known history of hyper- or hypo-pigmentation in the face.
* Known history of multiple allergies, allergic/anaphylactic reactions including allergy/ hypersensitivity to lidocaine, anaesthetics of the amide type, the used antiseptic components, the used antibiotic cream components.
* Known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment.
* Extensive skin laxity, thin skin and/or severe malar fat sagging.
* Foreign body sensitivity or known or suspected allergies to implant or instrument materials in particular plastic/biomaterial.
* Any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety/tolerance.
* Dental care in the past 2 weeks or who planned to receive dental care in the 2 months after the treatment.
* Anticoagulant (such as aspirin, warfarin, blood circulation enhancer and clotbuster) during the week before the injection session .
* Chemotherapy agents, immunosuppressive medications or systemic corticosteroids in the past 3 months and during the study.
* Lifting of the face in the past 12 months or other surgery of the face in the past 6 months.
* Resorbable fillers within the past 12 months, other resorbable threads within the past 12 months, neurotoxin in the past 5 months or plans to receive such treatments during the study.
* Permanent filler on the face.
* Subcutaneous permanent retaining structure on the face (meshing, permanent threads, gold strand etc.).
* Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06454994
Study Brief:
Protocol Section:
NCT06454994