Skin AgingNCT07145905
TCRM for Correction of Cheek Including Fine Lines
A study testing TCRM in people with Skin Aging and Cheek Wrinkles, run by Teoxane SA at 1 site in Spain.
Trial summary
The purpose of this clinical study is to evaluate benefits and risks of injecting TCRM in the cheek including fine lines. The goal is to show that treatment with TCRM will result in correcting the cheek area including the fine lines at 4 weeks after last treatment (initial injection or touch up) on subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Cheek Wrinkles
- What is being tested?
- TCRM
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- 30 Nov 2023to 31 Jan 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 the cheek area including fine lines.
- Subject scored grade 1 to 3 on the CFLDS.
- For women: not pregnant, not breast feeding
- 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 cheek area including fine lines 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.
Show all 9Show fewer
- Subject has unstable weight, as judged by the PI.
- Subject has no teeth or misses significant portion of dentition that changes the face appearance (subjects with dentures sufficiently replacing missing natural teeth are allowed).
- Subject under guardianship/tutorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-label, Multicenter, Interventional Study, to Evaluate Safety and Efficacy of TCRM in the Treatment of the Cheek Area Including Fine Lines: SPARKS
The purpose of this clinical study is to evaluate benefits and risks of injecting TCRM in the cheek including fine lines. The goal is to show that treatment with TCRM will result in correcting the cheek area including the fine lines at 4 weeks after last treatment (initial injection or touch up) on subjects.
- Conditions
- Skin Aging, Cheek Wrinkles
- Being tested
- TCRM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCRMDevice
N=128
| Study group | Role | What they receive |
|---|---|---|
| TCRM | Experimental | Treatments performed in this study include:
* An initial injection at V1 during which subjects will be injected with TCRM in the cheek area.
* An optional touch-up injection 4 weeks after the initial injection (at V2). Receives: Device: TCRM |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the efficacy of TCRM in the treatment of the cheek area including fine lines at 4 weeks after last injection (initial injection or touch up) using Global Aesthetic Improvement Scale (GAIS) as assessed by both subject and PI.
The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement.
Possible scores range from "much improved", "improved", "no change", "worse", to "much worse"
Measured: 4 weeks after last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start30 Nov 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teoxane SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145905
- Sponsor's protocol ID
- TEO-TCRM-2204
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2025
- Last updated
- 8 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 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Multicenter, Interventional Study, to Evaluate Safety and Efficacy of TCRM in the Treatment of the Cheek Area Including Fine Lines: SPARKS
- ClinicalTrials.gov ID
- NCT07145905
- Acronym / sponsor ID
- TEO-TCRM-2204
- Conditions
- Skin Aging, Cheek Wrinkles
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Teoxane SAIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 28 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.
The purpose of this clinical study is to evaluate benefits and risks of injecting TCRM in the cheek including fine lines. The goal is to show that treatment with TCRM will result in correcting the cheek area including the fine lines at 4 weeks after last treatment (initial injection or touch up) on subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TCRM | Experimental | Device: TCRMTreatments performed in this study include: * An initial injection at V1 during which subjects will be injected with TCRM in the cheek area. * An optional touch-up injection 4 weeks after the initial injection (at V2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy adult subjects over 18 years old seeking correction of the cheek area including fine lines.
- Subject scored grade 1 to 3 on the CFLDS.
- For women: not pregnant, not breast feeding
- 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
Key exclusion criteria (9 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 cheek area including fine lines 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 |
|---|---|---|
| TCRMN=128 | Device | TCRM |
Primary outcome
To demonstrate the efficacy of TCRM in the treatment of the cheek area including fine lines at 4 weeks after last injection (initial injection or touch up) using Global Aesthetic Improvement Scale (GAIS) as assessed by both subject and PI.
Time frame: 4 weeks after last injection
The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse"
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 8 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 TCRM in people with Skin Aging and Cheek Wrinkles, run by Teoxane SA at 1 site in Spain.
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 9 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 8 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 Spain. 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?
To demonstrate the efficacy of TCRM in the treatment of the cheek area including fine lines at 4 weeks after last injection (initial injection or touch up) using Global Aesthetic Improvement Scale (GAIS) as assessed by both subject and PI. (time frame: 4 weeks after last injection). 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 8 Sep 2025.