AgingLIFTUPNCT05986630
Safety and Effectiveness Evaluation of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face
A study testing TEOSYAL® TPVM and COMPARATOR in people with Aging and Chin Retrusion, run by Teoxane SA at 1 site in Switzerland.
Trial summary
The clinical study is designed to prospectively evaluate the safety and effectiveness of TEOSYAL® TPVM when compared to COMPARATOR for the remodeling of the lower face Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Chin Retrusion
- What is being tested?
- TEOSYAL® TPVM and COMPARATOR
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Apr 2023to 30 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Healthy adult subjects over 18 years old seeking correction of their lower face
- Subject scored grade 2 or 3 on the TCRS
- Female subjects of childbearing potential must have a negative UPT and practice a reliable method of contraception throughout the study.
- Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
- Able to follow study instructions and complete all required visits.
- Having given its signed 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.
- Subject exhibits any physical attribute that may prevent assessment or treatment of the lower face as judged by the PI
- Clinically significant alcohol or drug abuse.
- Subject has received any investigational product within 90 days prior to Visit 1 or planning to participate in another investigation during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Blinded Evaluator, Multicenter, Clinical Study to Evaluate Safety and Effectiveness of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face
The clinical study is designed to prospectively evaluate the safety and effectiveness of TEOSYAL® TPVM when compared to COMPARATOR for the remodeling of the lower face
Read the detailed description
This is a prospective, randomized, blinded evaluator, multicenter, clinical study to evaluate safety and effectiveness of TEOSYAL® TPVM versus COMPARATOR for the remodeling of the lower face.
Subject will be enrolled in the study based on evaluation of their chin retrusion severity.
For the purpose of this study, all injections will be done by principal investigators (PIs) with several years of experience in aesthetic treatment.
An external aesthetic and cosmetic surgeon will act as a BE to assess the performance of the treatment and the product based on photographs.
- Conditions
- Aging, Chin Retrusion
- Being tested
- TEOSYAL® TPVM, COMPARATOR
- Keywords
- Dermal filler, Hyaluronic acid (HA), Chin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEOSYAL® TPVMDevice
Injection of TEOSYAL® TPVM at Baseline
Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI.
COMPARATORDevice
Injection of a COMPARATOR at Baseline
Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI.
| Study group | Role | What they receive |
|---|---|---|
| TEOSYAL® TPVM | Experimental | n=116 subjects Receives: Device: TEOSYAL® TPVM |
| COMPARATOR | Active comparator | n= 39 subjects Receives: Device: COMPARATOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TCRS score between Baseline and 8 weeks after last treatment as assessed by the Blinded Evaluator
Non-inferiority of TCRS score change from Baseline for subjects treated with TEOSYAL TPVM compared to subjects treated with a COMPARATOR at 8 weeks after last treatment as assessed by the BE.
TCRS (Teoxane Chin Retrusion Scale) is a validated 4-point scale assessing chin retrusion severity with 0 being "None/minimal" and 3 being "Severe"
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start6 Apr 2023
- Primary completion21 Jul 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 155 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
- NCT05986630
- Sponsor's protocol ID
- TEO-TPVM-2101
- Acronym
- LIFTUP
- Status last verified
- Sep 2025
- First submitted
- 3 Aug 2023
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Blinded Evaluator, Multicenter, Clinical Study to Evaluate Safety and Effectiveness of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face
- ClinicalTrials.gov ID
- NCT05986630
- Acronym / sponsor ID
- LIFTUP / TEO-TPVM-2101
- Conditions
- Aging, Chin Retrusion
- Keywords
- Dermal filler, Hyaluronic acid (HA), Chin
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Teoxane SAIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Aug 2023 (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.
The clinical study is designed to prospectively evaluate the safety and effectiveness of TEOSYAL® TPVM when compared to COMPARATOR for the remodeling of the lower face
Detailed description
This is a prospective, randomized, blinded evaluator, multicenter, clinical study to evaluate safety and effectiveness of TEOSYAL® TPVM versus COMPARATOR for the remodeling of the lower face.
Subject will be enrolled in the study based on evaluation of their chin retrusion severity.
For the purpose of this study, all injections will be done by principal investigators (PIs) with several years of experience in aesthetic treatment.
An external aesthetic and cosmetic surgeon will act as a BE to assess the performance of the treatment and the product based on photographs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEOSYAL® TPVM | Experimental | Device: TEOSYAL® TPVMn=116 subjects |
| COMPARATOR | Active comparator | Device: COMPARATORn= 39 subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adult subjects over 18 years old seeking correction of their lower face
- Subject scored grade 2 or 3 on the TCRS
- Female subjects of childbearing potential must have a negative UPT and practice a reliable method of contraception throughout the study.
- Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
- Able to follow study instructions and complete all required visits.
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.
- Subject exhibits any physical attribute that may prevent assessment or treatment of the lower face as judged by the PI
- Clinically significant alcohol or drug abuse.
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 |
|---|---|---|
| TEOSYAL® TPVMInjection of TEOSYAL® TPVM at Baseline Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI. | Device | TEOSYAL® TPVM |
| COMPARATORInjection of a COMPARATOR at Baseline Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI. | Device | COMPARATOR |
Primary outcome
Change in TCRS score between Baseline and 8 weeks after last treatment as assessed by the Blinded Evaluator
Time frame: 8 weeks
Non-inferiority of TCRS score change from Baseline for subjects treated with TEOSYAL TPVM compared to subjects treated with a COMPARATOR at 8 weeks after last treatment as assessed by the BE. TCRS (Teoxane Chin Retrusion Scale) is a validated 4-point scale assessing chin retrusion severity with 0 being "None/minimal" and 3 being "Severe"
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 3 Sep 2025.
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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?
A study testing TEOSYAL® TPVM and COMPARATOR in people with Aging and Chin Retrusion, run by Teoxane SA at 1 site in Switzerland.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 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 Switzerland. 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?
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?
Change in TCRS score between Baseline and 8 weeks after last treatment as assessed by the Blinded Evaluator (time frame: 8 weeks). 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 3 Sep 2025.