Mild Defects of the LipsNCT07831213
Post-Market Clinical Follow-up (PMCF) Study of Safety and Performance of 300-01 RefillHA Lips
An observational study of Mild Defects of the Lips, run by Glyance at 1 site in Israel.
Trial summary
A Post-Market Observational Study of the Safety and Efficacy of RefillHA Lips for Remodelling and Correction of Mild Defects of the Lips Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Defects of the Lips
- How many people
- 87 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Jan 2024to 25 Feb 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
- Adult, Older adult
Study population: Subjects over the age of 18 who are seeking remodelling and/or correction of mild defects of the lips.
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
- Subjects with known contraindications to the treatment with RefillHA Lips, as per the device IFU.
- Patients with multiple and/or severe allergies or history of anaphylaxis.
- 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.
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- 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 a situation that, in the investigator's opinion, may put the subject at significant risk, or may significantly interfere with the subject's participation in the study or with protocol evaluation parameters.
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 Post-Market Observational Study of the Safety and Efficacy of RefillHA Lips for Remodelling and Correction of Mild Defects of the Lips.
A Post-Market Observational Study of the Safety and Efficacy of RefillHA Lips for Remodelling and Correction of Mild Defects of the Lips
Read the detailed description
This post-market, prospective, non-interventional, open label study is designed to demonstrate the performance and safety of RefillHA Lips in routine clinical practice for remodelling and correction of mild defects of the lips.
Subjects over 18 years old, willing to undergo non-surgical aesthetic procedures with RefillHA Lips will be offered to participate in the study. The investigators will enroll in any subject who receives at least one injection with RefillHA Lips 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 months 1, 3, 6, 9, and 12 from baseline, in accordance with the non-interventional study design. 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 through an area-specific assessment of the lips.
- Conditions
- Mild Defects of the Lips
- Keywords
- Mild defects of the lips
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 RefillHA Lips | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
The proportion of subjects with Global Aesthetic Improvement Scale (GAIS) scores 1-3 (responders) in the lips at months 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' (see Section 12.1).]
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 posted21 Sep 2026
- Study start18 Jan 2024
- Primary completion25 Feb 2027 (estimated)
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Defects of the LipsStudies 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
- NCT07831213
- Sponsor's protocol ID
- PMCF-300-01
- Status last verified
- Jan 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Observational Study of the Safety and Efficacy of RefillHA Lips for Remodelling and Correction of Mild Defects of the Lips.
- ClinicalTrials.gov ID
- NCT07831213
- Acronym / sponsor ID
- PMCF-300-01
- Conditions
- Mild Defects of the Lips
- Keywords
- Mild defects of the lips
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- GlyanceIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 25 Feb 2027 (estimated)
- First posted
- 21 Sep 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.
A Post-Market Observational Study of the Safety and Efficacy of RefillHA Lips for Remodelling and Correction of Mild Defects of the Lips
Detailed description
This post-market, prospective, non-interventional, open label study is designed to demonstrate the performance and safety of RefillHA Lips in routine clinical practice for remodelling and correction of mild defects of the lips.
Subjects over 18 years old, willing to undergo non-surgical aesthetic procedures with RefillHA Lips will be offered to participate in the study. The investigators will enroll in any subject who receives at least one injection with RefillHA Lips 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 months 1, 3, 6, 9, and 12 from baseline, in accordance with the non-interventional study design. 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 through an area-specific assessment of the lips.
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 RefillHA Lips | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects over the age of 18 who are seeking remodelling and/or correction of mild defects of the lips.
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 (11 listed)
- Subjects with known contraindications to the treatment with RefillHA Lips, as per the device IFU.
- Patients with multiple and/or severe allergies or history of anaphylaxis.
- 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.
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
Primary endpoint
Time frame: Up to 56 weeks after treatment
The proportion of subjects with Global Aesthetic Improvement Scale (GAIS) scores 1-3 (responders) in the lips at months 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' (see Section 12.1).]
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 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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 Mild Defects of the Lips, 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 11 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 21 Sep 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?
Primary endpoint (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 21 Sep 2026.