RecruitingNCT07495865
Post-market Clinical Follow-up (PMCF) Study of Safety and Performance of 502-01 AnGelHA 2
A Post-market, Prospective, Non-interventional, Open-label Study 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.
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