Post-market Clinical Follow-up (PMCF) Study of Safety and Performance of 502-01 AnGelHA 2 (NCT07495865) | Clinical Trial Compass
RecruitingNot Applicable
Post-market Clinical Follow-up (PMCF) Study of Safety and Performance of 502-01 AnGelHA 2
Israel87 participantsStarted 2026-02-08
Plain-language summary
Post-market clinical follow-up (PMCF) investigation to evaluate the performance and safety of AnGelHA 2 filler for the correction of moderate to severe wrinkles and folds and facial contour remodeling, in a routine clinical setting.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Men or women of any race, 18 years of age or older.
* Able to read, understand and sign informed consent.
Exclusion Criteria:
* Pregnant or lactating women (contraindications as per IFU).
* Having received prior dermal filler injections in the six months preceding the study.
* Previously treated with semi-permanent or permanent filler in the intended injection area.
* Presenting with a cutaneous disorder, inflammation or infection near to the treatment area.
* Known hypersensitivity to lidocaine and/or lidocaine HCl or hyaluronic acid.
* Metabolic or endocrine uncontrolled disease, anaphylaxis, severe allergies or uncontrolled immune disorder.
* Undergoing or planning to undergo peeling treatment or laser-/ultrasound-based treatment within 3 weeks before or after injection.
* Have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti- inflammatory drugs (NSAIDs such as aspirin, ibuprofen), or other substances known to prolong time of coagulation from a week before treatment. A wash-out period of a week is allowed.
* Subject, who has a condition or is in Fuse