WrinklesNCT07736703
A Clinical Investigation Comparing the Safety and Performance of RefillHA Solid With Hydryalix Ultra Deep Lidocaine for the Correction of Moderate-to-severe Nasolabial Folds
An observational study of Wrinkles and Folds, run by Glyance at 1 site in Israel.
Trial summary
Prospective, controlled, randomized, monocentric, double-blind, split-face non-inferiority clinical study to evaluate the safety and performance of injectable implant based on hyaluronic acid hydrogel with lidocaine for correction of moderate-to-severe nasolabial folds Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Dec 2024to 25 Jan 2026
- 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, seeking correction of moderate to severe nasolabial folds.
Who may be able to join
- Men or women of any race, 18 years of age or older.
- The presence of moderate to severe bilateral NLFs each with WSRS score of 3 or 4.
- NLFs of the same WSRS grade on the left and right sides of the face.
- Willing and able to read, understand and sign the informed consent.
- Willing to adhere to the protocol and to comply with the requirements of the entire investigation (ability to attend all the planned investigation visits according to the time limits included and report events and concomitant medication for the entire duration of investigation).
- Agree not to undergo other treatments or cosmetic procedures in the treatment area during the study, such as botulinum toxin, hyaluronic acid injections, facial laser treatments, fat injections, any other permanent or semi-permanent facial dermal fillers.
- Female subjects of childbearing potential must have a negative urine pregnancy test and must adopt an appropriate method of contraception for the entire duration of investigation.
Who cannot join
- Pregnant (as determined by a urine pregnancy test at the screening visit) or lactating women.
- Prior treatment (i.e., other permanent or biodegradable injectable fillers or surgical correction such as a face-lift, etc.) within 3 months prior to entry into the study or planned to undergo such treatment during the study.
- Previous treatment with permanent implants (e.g., silicone) in the area to be treated.
- Subjects who are currently or recently treated with laser, ultrasound or peeling, and who have not fully recovered from these treatments.
- Presence of active inflammation, infection, or unhealed wound of the face, such as acne, herpes, dermatitis, scaring etc.
- Presence of varices in the area to be treated.
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- History of hypertrophic scarring.
- Metabolic or endocrine serious diseases (e.g., uncontrolled diabetes or diabetes complications), anaphylaxis, severe allergies, immune disorders affecting the skin or other local or systemic concomitant diseases that may interfere with healing.
- Current neoplastic (including skin cancer) and/or immunodepressive diseases.
- Known hypocoagulability state.
- 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.
- Use of narcotic agents, antineoplastics, immunosuppressants or any other agent that may interfere with wound healing in the months before the screening visit.
- History of severe allergic/anaphylactic reactions or multiple allergies.
- 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 patient's participation in the study or with protocol evaluation parameters.
- Subjects considered to be unsuitable to participate, in the investigator's opinion, for any other reason.
- Subjects with known allergy or hypersensitivity to at least one component of any of the study medical devices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double-blinded, Controlled, Split-face, Non-inferiority Clinical Investigation Comparing the Safety and Performance of RefillHA Solid With Hydryalix Ultra Deep Lidocaine for the Correction of Moderate-to-severe Nasolabial Folds
Prospective, controlled, randomized, monocentric, double-blind, split-face non-inferiority clinical study to evaluate the safety and performance of injectable implant based on hyaluronic acid hydrogel with lidocaine for correction of moderate-to-severe nasolabial folds
Read the detailed description
This study will be a prospective, randomized, controlled, monocentric, double blind (evaluator/s and subject) within subject (split-face) non-inferiority clinical study. 40 Subjects will be randomized to be treated with RefillHA Solid in the NLF on one side of the face and comparator product in the NLF on the other side of the face. The side of the face for each product will be randomly assigned. The investigator performing the evaluations and the subject will be blinded to the treatment assignment. Injections of the study products will be performed by an unblinded Treating Investigator (TI).
At Visit 1 (considered baseline if no touch-up performed) eligible subjects, following signing informed consent, will receive injection of RefillHA Solid into left or right NLF, and injection of the control study device into the contralateral NLF (Initial treatment). for a given subject, the RefillHA Solid and control devices to be injected at the same depth between mid to deep dermis, and with the same technique, to be determined at the TI's discretion. The injected volume will be chosen by the TI and depend on the depth of wrinkle to be corrected. The minimum volume into a single NLF per injection session is 0.5 mL and the maximum volume is 2.5 mL, irrespective of the device.
At Visit 2, after 4 weeks from baseline, additional NLF correction with the study devices will be provided, if, per treating investigator's opinion, optimal correction was not achieved (touch-up treatment, considered baseline if performed). Only the NLF requiring touch-up will be treated using the same device as originally injected.
All subjects are scheduled to return for follow-up examinations at W4, W12, W24, W36 and W52 (Visits 3 to 7, respectively) after final treatment.
Subjects will be offered Early Re-Treatment at W24 or W36 (optional retreatment in case of facial asymmetry or if at least one NLF had returned to baseline level). Furthermore, Re-Treatment will be offered to all subjects attending the study visit in W52. Any Re-Treatment will be performed with the RefillHA Solid implant formulation used at the initial treatment, irrespective of the side of face treated.
- Keywords
- Wrinkles, Folds
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, seeking correction of moderate to severe nasolabial folds. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkle Severity Rating Scale (WSRS) Improvement Difference Between Treatment Groups at Week 24
Based on primary outcome - Wrinkle Severity Rating Scale (WSRS) improvement difference between treatment groups at week 24.
The improvement in WSRS will be analyzed by a non-inferiority statistical model with a 0.5 margin for the difference between treatment groups.
WSRS (Wrinkle Severity Rating Scale) is a validated 5-grade instrument for quantitative assessment of the severity of nasolabial folds. The aesthetic results of the treatment will be evaluated by the blind evaluator, separately for NLF on each side (right/left), using the 5-grade photonumeric WSRS. The grades are (grade 1) absent, (grade 2) mild, (grade 3) moderate, (grade 4) severe and (grade 5) extreme. The WSRS score ranges from 1 to 5, with higher scores indicating greater severity of nasolabial folds.
Measured: [Time Frame: 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 posted30 Jul 2026
- Study start8 Dec 2024
- Primary completion25 Jan 2026
- Study completion25 Jan 2026
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glyance
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736703
- Sponsor's protocol ID
- HA25L-01-24
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blinded, Controlled, Split-face, Non-inferiority Clinical Investigation Comparing the Safety and Performance of RefillHA Solid With Hydryalix Ultra Deep Lidocaine for the Correction of Moderate-to-severe Nasolabial Folds
- ClinicalTrials.gov ID
- NCT07736703
- Acronym / sponsor ID
- HA25L-01-24
- Keywords
- Wrinkles, Folds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlyanceIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2024 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- 25 Jan 2026 (actual)
- First posted
- 30 Jul 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.
Prospective, controlled, randomized, monocentric, double-blind, split-face non-inferiority clinical study to evaluate the safety and performance of injectable implant based on hyaluronic acid hydrogel with lidocaine for correction of moderate-to-severe nasolabial folds
Detailed description
This study will be a prospective, randomized, controlled, monocentric, double blind (evaluator/s and subject) within subject (split-face) non-inferiority clinical study. 40 Subjects will be randomized to be treated with RefillHA Solid in the NLF on one side of the face and comparator product in the NLF on the other side of the face. The side of the face for each product will be randomly assigned. The investigator performing the evaluations and the subject will be blinded to the treatment assignment. Injections of the study products will be performed by an unblinded Treating Investigator (TI).
At Visit 1 (considered baseline if no touch-up performed) eligible subjects, following signing informed consent, will receive injection of RefillHA Solid into left or right NLF, and injection of the control study device into the contralateral NLF (Initial treatment). for a given subject, the RefillHA Solid and control devices to be injected at the same depth between mid to deep dermis, and with the same technique, to be determined at the TI's discretion. The injected volume will be chosen by the TI and depend on the depth of wrinkle to be corrected. The minimum volume into a single NLF per injection session is 0.5 mL and the maximum volume is 2.5 mL, irrespective of the device.
At Visit 2, after 4 weeks from baseline, additional NLF correction with the study devices will be provided, if, per treating investigator's opinion, optimal correction was not achieved (touch-up treatment, considered baseline if performed). Only the NLF requiring touch-up will be treated using the same device as originally injected.
All subjects are scheduled to return for follow-up examinations at W4, W12, W24, W36 and W52 (Visits 3 to 7, respectively) after final treatment.
Subjects will be offered Early Re-Treatment at W24 or W36 (optional retreatment in case of facial asymmetry or if at least one NLF had returned to baseline level). Furthermore, Re-Treatment will be offered to all subjects attending the study visit in W52. Any Re-Treatment will be performed with the RefillHA Solid implant formulation used at the initial treatment, irrespective of the side of face treated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects over the age of 18, seeking correction of moderate to severe nasolabial folds. | – | – |
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, seeking correction of moderate to severe nasolabial folds.
Key inclusion criteria (7 listed)
- Men or women of any race, 18 years of age or older.
- The presence of moderate to severe bilateral NLFs each with WSRS score of 3 or 4.
- NLFs of the same WSRS grade on the left and right sides of the face.
- Willing and able to read, understand and sign the informed consent.
- Willing to adhere to the protocol and to comply with the requirements of the entire investigation (ability to attend all the planned investigation visits according to the time limits included and report events and concomitant medication for the entire duration of investigation).
Key exclusion criteria (16 listed)
- Pregnant (as determined by a urine pregnancy test at the screening visit) or lactating women.
- Prior treatment (i.e., other permanent or biodegradable injectable fillers or surgical correction such as a face-lift, etc.) within 3 months prior to entry into the study or planned to undergo such treatment during the study.
- Previous treatment with permanent implants (e.g., silicone) in the area to be treated.
- Subjects who are currently or recently treated with laser, ultrasound or peeling, and who have not fully recovered from these treatments.
- Presence of active inflammation, infection, or unhealed wound of the face, such as acne, herpes, dermatitis, scaring etc.
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
Wrinkle Severity Rating Scale (WSRS) Improvement Difference Between Treatment Groups at Week 24
Time frame: [Time Frame: Up to 56 weeks after treatment]
Based on primary outcome - Wrinkle Severity Rating Scale (WSRS) improvement difference between treatment groups at week 24. The improvement in WSRS will be analyzed by a non-inferiority statistical model with a 0.5 margin for the difference between treatment groups. WSRS (Wrinkle Severity Rating Scale) is a validated 5-grade instrument for quantitative assessment of the severity of nasolabial folds. The aesthetic results of the treatment will be evaluated by the blind evaluator, separately for NLF on each side (right/left), using the 5-grade photonumeric WSRS. The grades are (grade 1) absent, (grade 2) mild, (grade 3) moderate, (grade 4) severe and (grade 5) extreme. The WSRS score ranges from 1 to 5, with higher scores indicating greater severity of nasolabial folds.
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 19 Aug 2026.
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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 and 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 7 inclusion and 16 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 19 Aug 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?
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?
Wrinkle Severity Rating Scale (WSRS) Improvement Difference Between Treatment Groups at Week 24 (time frame: [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 19 Aug 2026.