Post-market Clinical Follow-up (PMCF) Study of Safety and Performance of 502-01 AnGelHA 2

NCT07495865 | Recruiting

• 1 other identifier: PMCF-502-01
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wrinkles

Keywords

Wrinkles

Outcome Measures

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.

  Up to 56 weeks after treatment

Study Arms (1)

Subjects over 18 years old, willing to undergo non-surgical aesthetic procedures with AnGelHA 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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)).

You may qualify if:

• Men or women of any race, 18 years of age or older.
• Able to read, understand and sign informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Glyance: lead

Study Sites (1)

Glyance Ltd

Lod, Israel, 7152026, Israel

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: February 8, 2026
• Primary Completion (Estimated): March 12, 2027
• Study Completion (Estimated): March 12, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-03

Locations

IL (1)