RecruitingNCT07495865
Post-market Clinical Follow-up (PMCF) Study of Safety and Performance of 502-01 AnGelHA 2
A Prospective, Open-label, Non-interventional Post-market Study Evaluating the Performance and Safety of AnGelHA 2 Filler for Correcting Moderate to Severe Wrinkles and Folds and Facial Contour Remodeling in Routine Clinical Use.
Sponsor
Glyance
Enrollment
87 participants
Start Date
Feb 8, 2026
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- Men or women of any race, 18 years of age or older.
- Able to read, understand and sign informed consent.
Exclusion Criteria9
- 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
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07495865