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 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT04166292
Eligibility Criteria:
Inclusion Criteria:
* Healthy Subject;
* Sex: male or female;
* Age: between 30 and 65 years;
* Subject having given freely and expressly his informed consent;
* Subject requiring injection on the cheekbones (upper part of the cheek);
* Subject with grade from 3 to 5 on the Facial Volume Loss Scale (FVLS);
* Subject, psychologically able to understand the study related information and to give a written informed consent;
* Subject affiliated to a health social security system;
* Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and during all the study;
* Subject agreeing to keep their usual cleansing / care products during the whole study period;
* Subject agreeing to apply a Sun Protection Factor (SPF) 50 cream during non-intensive exposure to sunlight.
Exclusion Criteria:
In terms of population
* Pregnant or nursing woman or planning a pregnancy during the study;
* Subject with a scar, moles or anything on the face which might interfere with the evaluation;
* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;
* Subject in a social or sanitary establishment;
* Subject participating to another research on human beings or who is in an exclusion period of one;
* Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
* Intensive exposure to sunlight or Ultraviolet-rays (UV-rays) within the month before each visit;
In terms of associated pathology
* Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results;
* Subject with known history of or suffering from autoimmune disease and/or immune deficiency;
* Subject suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma…). Subject with recurrent herpes is not eligible even if asymptomatic at time of inclusion;
* Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders
* Subject having history of allergy or anaphylactic shock including hypersensitivity to hyaluronic acid or to one of the components of the tested device;
* Subject having history of allergy or anaphylactic shock including hypersensitivity to amide-type local anaesthetics or antiseptic solution;
* Subject with a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats;
* Subject with a tendency to develop keloids or hypertrophic scars;
* Subject with haemostatic disorder;
* Subject with porphyria;
Relating to previous or ongoing treatment
* Subject having received treatment with a laser, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the face within the past 12 months prior to inclusion;
* Subject having received injection with a resorbable filling product in the face area within the past 18 months prior to inclusion;
* Subject having received at any time injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of hyaluronic acid (HA) and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), …) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …);
* Subject having received at any time a treatment with tensor threads on the face;
* Subject having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to inclusion;
* Subject under medications that reduce or inhibit hepatic metabolism;
* Subject under medications which may cause lipo-atrophy;
* Subject using medication such as aspirin, NSAIDs (ibuprofen, naproxen, …), antiplatelet agents, anticoagulants, vitamin C within one week prior to inclusion and agreeing not to take such treatments within 1 week prior to visit 2 (M1) or being a chronic user;
* Subject undergoing a topical treatment on the test area or a systemic treatment;
* anti-histamines during the 2 weeks prior to study start;
* immunosuppressors and/or corticoids during the 4 weeks prior to study start;
* retinoids during the 6 months prior to study start.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT04166292
Study Brief:
Protocol Section:
NCT04166292