Wrinkles Such as Nasolabial FoldsNCT07109635
Post Market Study of Safety and Performance of RefillHA Volume+ for Facial Soft Tissue Augmentation and Correction of Wrinkles and Folds
An observational study of Wrinkles Such as Nasolabial Folds, run by Glyance at 1 site in Israel.
Trial summary
This post market study was designed to collect clinical data regarding the safety and performance of RefillHA Volume+ upon its launch, from patients treated with the product in a routine clinical setting of treatments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkles Such as Nasolabial Folds
- How many people
- 46 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Feb 2024to 18 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 over the age of 18 who are seeking correction of facial wrinkles and folds and/or soft tissue augmentation.
Who may be able to join
- Adult men and women, over the age of 18, seeking correction of facial wrinkles and folds and/or soft tissue augmentation.
- Subjects who are willing and able to read, understand and sign informed consent.
Who cannot join
- Subjects with known contraindications to the treatment (as per device IFU).
- Subjects considered to be unsuitable to participate, in the investigator's opinion, for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post Market Non-Interventional Study of Safety and Performance of RefillHA Volume+, a Dermal Filler for Facial Soft Tissue Augmentation and Correction of Facial Wrinkles and Folds
This post market study was designed to collect clinical data regarding the safety and performance of RefillHA Volume+ upon its launch, from patients treated with the product in a routine clinical setting of treatments.
In this study, patients seeking correction of facial wrinkles and folds and/or soft tissue augmentation who are candidates for treatment with RefillHA Volume+ according to its approved use will be offered to participate in the study. Eligible patients who are willing to participate in the study, after signing an informed consent, will be treated with RefillHA Volume+ in the facial regions where correction is requested, subject to the advice of the treating physician and in accordance with the approved use.
Read more
After recieving initial treatment, participants will attend 2 to 4 in-clinic follow-up visits, during which they will be eligible to receive additional treatment with RefillHA Volume+ (up to two additional treatments during the follow-up period) if, per treating investigator's opinion, additional treatment is required for better correction or to maintain the results.
Clinical data were collected at all in clinic visits, including standardized facial photographs, pain perception self-assessement was recorded by subjects immediately after treatment. All subjects were asked for details of any Adverse Events (AEs) they had experienced. Subjects were asked to rate aesthetic results and Patient Satisfaction questionnaire at each follow-up visit. Physicians were asked to rate aesthetic results as well and details of the treatment session were recorded.
- Conditions
- Wrinkles Such as Nasolabial Folds
- 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 the age of 18 who are seeking correction of facial wrinkles and folds and/or soft tiss | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. The frequency of reported adveres events (number of participants who experienced each reported adverse event) 2. The severity of reported adverse events (1=mild, 2=moderate, 3=severe)
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 posted7 Aug 2025
- Study start19 Feb 2024
- Primary completion28 Oct 2024
- Study completion18 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkles Such as Nasolabial FoldsStudies 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
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glyance
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109635
- Sponsor's protocol ID
- PMCF-SP-200-02
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Non-Interventional Study of Safety and Performance of RefillHA Volume+, a Dermal Filler for Facial Soft Tissue Augmentation and Correction of Facial Wrinkles and Folds
- ClinicalTrials.gov ID
- NCT07109635
- Acronym / sponsor ID
- PMCF-SP-200-02
- Conditions
- Wrinkles Such as Nasolabial Folds
- Keywords
- wrinkles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- GlyanceIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 18 May 2025 (actual)
- First posted
- 7 Aug 2025 (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.
This post market study was designed to collect clinical data regarding the safety and performance of RefillHA Volume+ upon its launch, from patients treated with the product in a routine clinical setting of treatments.
In this study, patients seeking correction of facial wrinkles and folds and/or soft tissue augmentation who are candidates for treatment with RefillHA Volume+ according to its approved use will be offered to participate in the study. Eligible patients who are willing to participate in the study, after signing an informed consent, will be treated with RefillHA Volume+ in the facial regions where correction is requested, subject to the advice of the treating physician and in accordance with the approved use.
After recieving initial treatment, participants will attend 2 to 4 in-clinic follow-up visits, during which they will be eligible to receive additional treatment with RefillHA Volume+ (up to two additional treatments during the follow-up period) if, per treating investigator's opinion, additional treatment is required for better correction or to maintain the results.
Clinical data were collected at all in clinic visits, including standardized facial photographs, pain perception self-assessement was recorded by subjects immediately after treatment. All subjects were asked for details of any Adverse Events (AEs) they had experienced. Subjects were asked to rate aesthetic results and Patient Satisfaction questionnaire at each follow-up visit. Physicians were asked to rate aesthetic results as well and details of the treatment session were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects over the age of 18 who are seeking correction of facial wrinkles and folds and/or soft tiss | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects over the age of 18 who are seeking correction of facial wrinkles and folds and/or soft tissue augmentation.
Key inclusion criteria (2 listed)
- Adult men and women, over the age of 18, seeking correction of facial wrinkles and folds and/or soft tissue augmentation.
- Subjects who are willing and able to read, understand and sign informed consent.
Key exclusion criteria (2 listed)
- Subjects with known contraindications to the treatment (as per device IFU).
- Subjects considered to be unsuitable to participate, in the investigator's opinion, for any reason.
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
1. The frequency of reported adveres events (number of participants who experienced each reported adverse event) 2. The severity of reported adverse events (1=mild, 2=moderate, 3=severe)
Time frame: Up to 56 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Such as Nasolabial Folds, 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 2 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: finished, as of the sponsor's last update on 7 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. The frequency of reported adveres events (number of participants who experienced each reported adverse event) 2. The severity of reported adverse events (1=mild, 2=moderate, 3=severe) (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 7 Aug 2025.