Post-market Clinical Follow-up (PMCF) Study of Safety and Performance of 502-01 AnGelHA 2
ConditionWrinkles
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGlyance
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Men or women of any race, 18 years of age or older.
Able to read, understand and sign informed consent.
Disqualifiers
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.
Trial population
Subjects of any race over 18 years old, willing to undergo non-surgical aesthetic procedure in at least one of the indications for which AnGelHA 2 is intended (correction of nasolabial folds, marionette lines and/or facial contour remodeling (temples, cheekbones, jawline, chin)).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
87 Participants
are grouped into 1 trial groupGroup A: Subjects over 18 years old, willing to undergo non-surgical aesthetic procedures with AnGelHA 2
Trial outcomes
Primary outcomes
1
Number of Participants with Improvement in iGAIS
The Proportion of subjects with Global Aesthetic Improvement Scale (GAIS) scores 1-3 (improved) in whole facial appearance at months 1, 3, 6, 9 and 12 after initial injection, as assessed by the investigator (iGAIS). \[Scores 1-3 correspond to 'Very much improved', 'Much improved', and 'Improved' \]. Proportion of subjects with GAIS scores 1-3 (improved) in whole facial appearance at months 1, 3, 6, 9 and 12 after initial injection, as assessed by the subject (sGAIS). Also, the average sGAIS, and confidence interval for both. In addition, performance will be evaluated per injected area: Nasolabial Folds, Temples, Cheekbones, Jawline and/or chin, Marionette lines.
Time frame
Up to 56 weeks after treatment Source ClinicalTrials.gov