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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT03537456
Eligibility Criteria:
Inclusion Criteria:
* Men or women with age \> 35 and ≤ 65 years;
* Subjects seeking tissue augmentation treatment on the face;
* Subjects willing to receive HA Filler for one and/or more mimetic and/or superficial facial wrinkles located in the facial area including periocular area;
* Subjects willing to receive HA Filler for one and/or more mimetic and/or superficial facial wrinkles;
* Subjects willing to provide signed informed consent to clinical investigation participation.
Exclusion Criteria:
* Use of aspirin and antiplatelet agents a week prior to treatment;
* Pregnant or lactating women;
* Subjects with a history of allergy or hypersensitivity to the HA or to other ingredients of the dermal filler;
* Subjects with hypersensitivity to salicylic acid or any of its derivates;
* Subjects with any dermal systemic pathologies, such as systemic lupus erythematosus, psoriasis, scleroderma etc.;
* Subjects presenting bleeding disorders in the past or present;
* Subjects taking or having indications for anticoagulant therapy;
* Use of concomitant treatments or procedures aimed to improve skin rejuvenation over the last six months before the clinical investigation enrolment, such as chemical peeling, dermabrasion, laser resurfacing;
* Subjects suffering from infectious diseases including herpes simplex virus infection, active hepatitis or human immunodeficiency virus;
* Subjects suffering from eczema, acne, and keloids;
* Subjects with any cutaneous manifested infection, disease or alteration;
* Subjects at risk in term of precautions, warnings, and contra-indications referred in the package insert of the clinical investigation device;
* Subjects with any facial aesthetic surgery in the preceding 12 months before the clinical investigation enrolment;
* Subjects with any active irritation or inflammation in the target areas of injection;
* Subjects who received botulinum toxin A injections in the face in the preceding 6 months;
* Subjects unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits;
* Subjects with solar activity, such as prolonged exposure to the sun, UV rays and extreme conditions of heat for at least a week after the treatment
* Direct or indirect contact with quaternary ammonium salts during the investigation
* Subjects participating in another clinical investigation or treated with another HA filler with the same indications at the same time or within the preceding 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT03537456
Study Brief:
Protocol Section:
NCT03537456