WrinklesNCT07495865
Post-market Clinical Follow-up (PMCF) Study of Safety and Performance of 502-01 AnGelHA 2
An observational study of Wrinkles, run by Glyance at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkles
- How many people
- 87 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Feb 2026to 12 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)).
Who may be able to join
- Men or women of any race, 18 years of age or older.
- Able to read, understand and sign informed consent.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Glyance Ltd
Lod, Israel, 7152026
Rachel Shemesh, +972535514894, rachel@axecium.com
About this study
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.
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.
Read the 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.
- Conditions
- Wrinkles
- Keywords
- Wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects over 18 years old, willing to undergo non-surgical aesthetic procedures with AnGelHA 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 56 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start8 Feb 2026
- Primary completion12 Mar 2027 (estimated)
- Study completion12 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glyance
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495865
- Sponsor's protocol ID
- PMCF-502-01
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07495865
- Acronym / sponsor ID
- PMCF-502-01
- Conditions
- Wrinkles
- Keywords
- Wrinkles
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- GlyanceIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2026 (actual)
- Primary completion
- 12 Mar 2027 (estimated)
- Study completion
- 12 Mar 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects over 18 years old, willing to undergo non-surgical aesthetic procedures with AnGelHA 2 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)).
Key inclusion criteria (2 listed)
- Men or women of any race, 18 years of age or older.
- Able to read, understand and sign informed consent.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Improvement in iGAIS
Time frame: Up to 56 weeks after treatment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrinkles, run by Glyance at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Improvement in iGAIS (time frame: Up to 56 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.