Post-market follow-up of AnGelHA 2 hyaluronic acid filler for wrinkles and facial contouring
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.
This project will try AnGelHA 2 filler to reduce moderate to severe facial wrinkles and improve facial contours in adults seeking non-surgical aesthetic injections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 87 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Glyance Industry-sponsored |
| Locations | 1 site (Lod, Israel) |
| Trial ID | NCT07495865 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-interventional, open-label post-market follow-up of AnGelHA 2 administered in routine clinical practice. Adult participants who receive at least one injection with AnGelHA 2 are enrolled and treated according to the practitioner's usual technique, volume, depth, and retreatment decisions. Safety and performance are tracked with area-specific and whole-face appearance assessments and routine safety monitoring. Follow-up visits are optional and planned at 1, 3, 6, 9, and 12 months after baseline, with additional visits allowed as needed.
Who should consider this trial
Good fit: Adults aged 18 or older who want non-surgical injections for moderate to severe facial wrinkles or contouring, can provide informed consent, and do not have contraindications such as pregnancy, recent filler in the target area, or known hypersensitivity are ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, have had dermal filler in the prior six months or permanent fillers in the intended area, have active skin infection or inflammation near the treatment site, known allergy to hyaluronic acid or lidocaine, or uncontrolled medical conditions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, AnGelHA 2 may offer a safe and effective option to reduce moderate to severe facial wrinkles and improve facial contour using routine non-surgical injections.
How similar studies have performed: Numerous clinical and post-market studies of hyaluronic acid fillers have demonstrated favorable safety and performance for wrinkle correction, so this approach aligns with existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lod, Israel
- Glyance Ltd — Lod, Israel, Israel (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.