Infraorbital HollowsNCT06749587
TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese Adults
A study testing TEOSYAL RHA® 1 in people with Infraorbital Hollows, run by Teoxane SA at 1 site in China.
Trial summary
This is a prospective, multi-center, randomized, no-treatment controlled, evaluator-blinded clinical investigation to identify whether TEOSYAL RHA® 1 is superior to no treatment for the correction of moderate to severe tissue volume deficiencies in the infraorbital region 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
- Infraorbital Hollows
- What is being tested?
- TEOSYAL RHA® 1
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2024to 12 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
- Chinese male and female, 18 years of age or older.
- Subject seeking treatment of moderate to severe tissue volume deficiencies in the infraorbital region.
- Subjects with a grade of 2 (moderate) or 3 (severe) on the TIOHS for both eyes, as determined on assessments by the Treating Investigator (TI) and BLE.
- 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 agree to use contraception during the investigation.
- Subject understands and is able to follow instructions and complete all scheduled visits.
- Subjects who voluntarily decided to participate in the investigation and signed the informed consent.
Who cannot join
- Known hypersensitivity or previous allergic reaction to any component of the study device.
- 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Second Provincial General Hospital
Guangzhou
About this study
Official title: A Prospective, Multi-center, Randomized, No-Treatment Controlled, Evaluator-Blinded, Superiority Clinical Investigation of the Safety and Effectiveness of TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese Adults
This is a prospective, multi-center, randomized, no-treatment controlled, evaluator-blinded clinical investigation to identify whether TEOSYAL RHA® 1 is superior to no treatment for the correction of moderate to severe tissue volume deficiencies in the infraorbital region in Chinese adults.
Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 3:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL RHA® 1 in both Infraorbital Hollows (IOH), whereas subjects assigned to the control group will not receive any treatment.
Read more
The subjects in the treatment group will be treated with RHA1 for the treatment of moderate to severe tissue volume deficiencies in the infraorbital region on Day 0.
All treated subjects will return to the site at 2, 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and safety assessments. Each treated subjects will receive a safety phone call 3 days after the initial treatment at baseline, and after the touch-up treatment, if any. Their participation in the trial ends after the completion of the follow up period.
All non treated subjects (control group) will return to the site at 2, 4, and 12 weeks after randomization for effectiveness and safety assessments. Their participation in the investigation ends after the effectiveness and safety assessments at 12 weeks after randomization.
- Conditions
- Infraorbital Hollows
- Being tested
- TEOSYAL RHA® 1
- Keywords
- Dermal Filler, Hyaluronic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEOSYAL RHA® 1Device
Product injection in infraorbital hollows
TEOSYAL RHA® 1 is a sterile, transparent, non-pyrogenic, viscoelastic gel made of Hyaluronic Acid (HA) of non-animal origin
| Study group | Role | What they receive |
|---|---|---|
| TEOSYAL RHA® 1 | Experimental | Not described Receives: Device: TEOSYAL RHA® 1 |
| Control group (non treated) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIOHS = Teoxane Infraorbital Hollows Scale (grade 0 = no visible infraorbital hollow ; grade 4 = very severe infraorbital hollow)
Proportion of responders, defined by at least 1-grade improvement in both eyes from baseline 5-point TIOHS, as assessed by the BLE at 12 weeks after treatment.
Measured: 12 weeks after the last treatment for the treatment group / 12 weeks after randomization for the control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start12 Dec 2024
- Primary completion12 Mar 2025 (estimated)
- Study completion12 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infraorbital HollowsStudies 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
- 260 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
- NCT06749587
- Sponsor's protocol ID
- TEO-TPRL-2401
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, No-Treatment Controlled, Evaluator-Blinded, Superiority Clinical Investigation of the Safety and Effectiveness of TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese Adults
- ClinicalTrials.gov ID
- NCT06749587
- Acronym / sponsor ID
- TEO-TPRL-2401
- Conditions
- Infraorbital Hollows
- Keywords
- Dermal Filler, Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Teoxane SAIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 12 Mar 2025 (estimated)
- Study completion
- 12 Jan 2026 (estimated)
- First posted
- 27 Dec 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, no-treatment controlled, evaluator-blinded clinical investigation to identify whether TEOSYAL RHA® 1 is superior to no treatment for the correction of moderate to severe tissue volume deficiencies in the infraorbital region in Chinese adults.
Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 3:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL RHA® 1 in both Infraorbital Hollows (IOH), whereas subjects assigned to the control group will not receive any treatment.
The subjects in the treatment group will be treated with RHA1 for the treatment of moderate to severe tissue volume deficiencies in the infraorbital region on Day 0.
All treated subjects will return to the site at 2, 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and safety assessments. Each treated subjects will receive a safety phone call 3 days after the initial treatment at baseline, and after the touch-up treatment, if any. Their participation in the trial ends after the completion of the follow up period.
All non treated subjects (control group) will return to the site at 2, 4, and 12 weeks after randomization for effectiveness and safety assessments. Their participation in the investigation ends after the effectiveness and safety assessments at 12 weeks after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEOSYAL RHA® 1 | Experimental | Device: TEOSYAL RHA® 1 |
| Control group (non treated) | No intervention | – |
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 seeking treatment of moderate to severe tissue volume deficiencies in the infraorbital region.
- Subjects with a grade of 2 (moderate) or 3 (severe) on the TIOHS for both eyes, as determined on assessments by the Treating Investigator (TI) and BLE.
- 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 agree to use contraception during the investigation.
Key exclusion criteria (6 listed)
- Known hypersensitivity or previous allergic reaction to any component of the study device.
- 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 |
|---|---|---|
| TEOSYAL RHA® 1Product injection in infraorbital hollows TEOSYAL RHA® 1 is a sterile, transparent, non-pyrogenic, viscoelastic gel made of Hyaluronic Acid (HA) of non-animal origin | Device | TEOSYAL RHA® 1 |
Primary outcome
TIOHS = Teoxane Infraorbital Hollows Scale (grade 0 = no visible infraorbital hollow ; grade 4 = very severe infraorbital hollow)
Time frame: 12 weeks after the last treatment for the treatment group / 12 weeks after randomization for the control group
Proportion of responders, defined by at least 1-grade improvement in both eyes from baseline 5-point TIOHS, as assessed by the BLE at 12 weeks after treatment.
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 28 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Infraorbital Hollows
Not yet recruitingPhase 2
Phase 2 Evaluation of Recombinant Human Platelet-Derived Growth Factor-BB (rhPDGF-BB) Injection for the Treatment of Infraorbital Hollowing
Infra-orbital Hollows, Skin Quality Improvement
Recruiting
Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
Lips Enhancement, Perioral Wrinkles
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?
A study testing TEOSYAL RHA® 1 in people with Infraorbital Hollows, 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: looking for participants now, as of the sponsor's last update on 28 Jan 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 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?
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?
Contact Elise Gondard (+41223449636, e.gondard@teoxane.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIOHS = Teoxane Infraorbital Hollows Scale (grade 0 = no visible infraorbital hollow ; grade 4 = very severe infraorbital hollow) (time frame: 12 weeks after the last treatment for the treatment group / 12 weeks after randomization for the control group). 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 28 Jan 2025.