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

Official title

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.

Overview

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.

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.

Primary outcome measures

• Number of Participants with Improvement in iGAIS [Time frame: Up to 56 weeks after treatment]

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.
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Israel · 1 center

• Glyance Ltd — Lod

Identifiers

NCT: NCT07495865 · PMCF-502-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗