Nasolabial FoldsNCT06367634
TEOSYAL® PureSense ULTRA DEEP Versus Restylane® Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults
A study testing injection in NLF in people with Nasolabial Folds, run by Teoxane SA at 1 site in China.
Trial summary
This is a prospective, multi-center, randomized, controlled, subject- and evaluator-blinded clinical investigation to demonstrate non-inferiority of TEOSYAL® PureSense ULTRA DEEP compared to Restylane® Lidocaine for the correction of moderate to severe NLF in Chinese adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- injection in NLF
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2024to Feb 2026
- Phase
- Interventional
- 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
Who may be able to join
- Chinese male and female, 18 years of age or older.
- Subject desiring bilateral NLF treatment.
- Has symmetrical NLFs, with the same WSRS score of 3 (moderate) or 4 (severe) for both right and left NLFs, as determined on live assessment by the blinded evaluator.
- Subject willing to abstain from all other facial aesthetic procedures/therapies that could interfere with effectiveness evaluations (e.g., dermal fillers outside of this investigation, toxin treatments, facial ablative or fractional laser, intense pulsed light [IPL], microdermabrasion, chemical peels, skin bleaching agents, non-ablative laser, or energy-based device for skin-tightening, surgical procedures, etc.) during participation in the investigation.
- Woman of childbearing potential must be using a highly effective method of birth control .
- Subject understands and is able to follow instructions and complete all scheduled visits.
- Subjects who voluntarily decided the participation of the investigation and signed the informed consent.
Who cannot join
- Known hypersensitivity or previous allergic reaction to any component of the study devices
- Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
- History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
- History of connective tissue disease.
- Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
- Subjects who participated in other clinical investigation within 30 days, or in an exclusion period from a previous study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Second Provincial General Hospital
Guangzhou
About this study
Official title: A Prospective, Multi-Center, Randomized, Controlled, Subject- and Evaluator-Blinded, Non-Inferior Clinical Investigation of the Safety and Effectiveness of TEOSYAL® PureSense ULTRA DEEP Versus Restylane® Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults
This is a prospective, multi-center, randomized, controlled, subject- and evaluator-blinded clinical investigation to demonstrate non-inferiority of TEOSYAL® PureSense ULTRA DEEP compared to Restylane® Lidocaine for the correction of moderate to severe NLF in Chinese adults.
Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 1:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL® PureSense ULTRA DEEP in both NLFs, whereas subjects assigned to the control group will receive Restylane® Lidocaine.
Read more
The treating investigator will administer the corresponding product in both NLFs of the subject on Day 0.
All subjects will return to the site at 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and safety assessment. All subjects will receive a safety phone call 7 days after the initial treatment at baseline, and after the touch-up treatment, if applicable.
- Conditions
- Nasolabial Folds
- Being tested
- injection in NLF
- Keywords
- Dermal Filler, Hyaluronic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection in NLFDevice
TEOSYAL® PureSense ULTRA DEEP is a sterile, transparent, non-pyrogenic, viscoelastic gel made of HA of non-animal origin
| Study group | Role | What they receive |
|---|---|---|
| Ultra Deep | Experimental | Not described Receives: Device: injection in NLF |
| Restylane | Active comparator | Not described Receives: Device: injection in NLF |
What is being measured
The primary outcome is the main question the study is designed to answer.
WSRS grading
Proportion of responders, defined by at least 1-point improvement from baseline 5-point WSRS, as measured by the blinded live evaluator at 24 weeks after the last treatment
Measured: 24 weeks after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start19 Jan 2024
- Primary completionJan 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teoxane SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367634
- Sponsor's protocol ID
- TEO-TSUL-2301
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 16 Apr 2024
- 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 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Randomized, Controlled, Subject- and Evaluator-Blinded, Non-Inferior Clinical Investigation of the Safety and Effectiveness of TEOSYAL® PureSense ULTRA DEEP Versus Restylane® Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults
- ClinicalTrials.gov ID
- NCT06367634
- Acronym / sponsor ID
- TEO-TSUL-2301
- Conditions
- Nasolabial Folds
- Keywords
- Dermal Filler, Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Teoxane SAIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 16 Apr 2024 (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 is a prospective, multi-center, randomized, controlled, subject- and evaluator-blinded clinical investigation to demonstrate non-inferiority of TEOSYAL® PureSense ULTRA DEEP compared to Restylane® Lidocaine for the correction of moderate to severe NLF in Chinese adults.
Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 1:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL® PureSense ULTRA DEEP in both NLFs, whereas subjects assigned to the control group will receive Restylane® Lidocaine.
The treating investigator will administer the corresponding product in both NLFs of the subject on Day 0.
All subjects will return to the site at 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and safety assessment. All subjects will receive a safety phone call 7 days after the initial treatment at baseline, and after the touch-up treatment, if applicable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultra Deep | Experimental | Device: injection in NLF |
| Restylane | Active comparator | Device: injection in NLF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chinese male and female, 18 years of age or older.
- Subject desiring bilateral NLF treatment.
- Has symmetrical NLFs, with the same WSRS score of 3 (moderate) or 4 (severe) for both right and left NLFs, as determined on live assessment by the blinded evaluator.
- Subject willing to abstain from all other facial aesthetic procedures/therapies that could interfere with effectiveness evaluations (e.g., dermal fillers outside of this investigation, toxin treatments, facial ablative or fractional laser, intense pulsed light [IPL], microdermabrasion, chemical peels, skin bleaching agents, non-ablative laser, or energy-based device for skin-tightening, surgical procedures, etc.) during participation in the investigation.
- Woman of childbearing potential must be using a highly effective method of birth control .
Key exclusion criteria (6 listed)
- Known hypersensitivity or previous allergic reaction to any component of the study devices
- Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
- History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
- History of connective tissue disease.
- Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection in NLFTEOSYAL® PureSense ULTRA DEEP is a sterile, transparent, non-pyrogenic, viscoelastic gel made of HA of non-animal origin | Device | Restylane, Ultra Deep |
Primary outcome
WSRS grading
Time frame: 24 weeks after last treatment
Proportion of responders, defined by at least 1-point improvement from baseline 5-point WSRS, as measured by the blinded live evaluator at 24 weeks after the last treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Nasolabial Folds
Recruiting
A Study to Confirm Safety and Effectiveness of RADIESSE® Injectable Implant for the Correction of Moderate to Severe Nasolabial Folds
Nasolabial Folds
Not yet recruiting
Dermal Evaluation of Facetem™ S in Nasolabial Folds Esthetics Improvement: DEFINE Study
Nasolabial Folds
Active, not recruiting
Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
Nasolabial Fold
RecruitingPhase 3
Study to Assess Adverse Events and How Effective NOA LIFT is Compared to JUVÉDERM VOLIFT With Lidocaine for the Correction of Nasolabial Folds in Adults
Nasolabial Folds
Recruiting
THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER
Lips Enhancement Nasolabial Fold Correction Midface Volume Deficit
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection in NLF in people with Nasolabial Folds, run by Teoxane SA at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elise Gondard (+41 22 344 96 36, e.gondard@teoxane.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WSRS grading (time frame: 24 weeks after last 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 16 Apr 2024.