Post-market Clinical Follow-up (PMCF) Study of Safety and Performance of 502-01 AnGelHA 2
Recruiting
Observational Study
Wrinkles
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
87 (estimated)
Sponsor
Glyance · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
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.…
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
Contacts
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