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.

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.

Study Overview

• Status: Recruiting
• Conditions: Wrinkles

Detailed Description

This post-market, prospective, non-interventional, open-label study designed to demonstrate the performance and safety ofAnGelHA 2 in routine clinical practice.

Subjects over 18 years old, who are willing to undergo non-surgical aesthetic procedures with AnGelHA 2 will be offered to participate in the study. The investigators will enroll in any subject who receives at least one injection withAnGelHA 2 and have provided informed consent. They will follow their routine practice regarding injection technique, volume, and subject follow-up. Treatments will be performed for a single indication or for multiple indications where correction is requested, subject to the advice of the practitioner and in accordance with the product intended use and conditions. Any indication can be retreated at any time throughout the duration of the study, as per routine practice. The area to be treated and injection characteristics-volume, depth, and technique- are all left to the discretion of the practitioner.

The study protocol includes an initial visit (baseline) and follow-up visits at 1, 3, 6, 9, and 12 months from baseline, which are optional as per the non-interventional study design (Figure 1). Additional visits are allowed at any time throughout the follow-up period at the patient's request or when deemed necessary. At each visit, in addition to the safety assessment, performance will be evaluated for each injected area through an area-specific assessment as well as whole facial appearance.

• Study Type: Observational
• Enrollment (Estimated): 87

Contacts and Locations

Study Locations

• Israel
  • Israel
    • Lod, Israel, Israel, 7152026
      • Recruiting
      • Glyance Ltd
      • Contact: Rachel Shemesh; Phone Number: +972535514894; Email: rachel@axecium.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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)).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Glyance

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2026
• Primary Completion (Estimated): March 12, 2027
• Study Completion (Estimated): March 12, 2027

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Wrinkles
• Other Study ID Numbers: PMCF-502-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No