Infra-orbital HollowsNCT04577898
RHA® Redensity Eye Versus No-treatment for the Infra-Orbital Hollows
A study testing RHA® Redensity Eye in people with Infra-orbital Hollows and Tear-trough Deformity, run by Teoxane SA at 4 sites in United States.
Trial summary
This is a multicenter, blinded evaluator, randomized, prospective, no treatment control clinical study to identify whether RHA® Redensity Eye (*) is superior to no treatment for the correction of moderate to severe tissue volume deficiencies in the infraorbital regions. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infra-orbital Hollows, Tear-trough Deformity, Wrinkle
- What is being tested?
- RHA® Redensity Eye
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Dec 2020to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatient, male or female of any race, 22 years of age or older
- Infra-orbital Hollows of grade 2 to 3 on the TIOHS (ranging from 0 to 4) who is seeking treatment of moderate to severe tissue volume deficiencies in the infra-orbital region (realistic and achievable as per TI opinion). Bilateral symmetry is not required. If the assessments of the TI and the BLE are the same or differ by exactly 1 point on the scale, this difference is considered acceptable. If the subject is eligible, the BLE's assessment will be used for the Baseline for the primary endpoint. If the TI and the BLE do not agree on eligibility, or if their assessments differ by 2 points or more on the scale, the subject will not be eligible.
- Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
- Able to follow study instructions and complete all required visits.
- Sign the IRB-approved ICF, Photographic Release Form and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study- related procedures being performed.
Who cannot join
- Female subjects that are pregnant, breast-feeding or of childbearing potential and not practicing reliable birth control
- Known hypersensitivity/allergy to any component of the study devices
- Clinically significant active skin disease within 6 months
- Has a history of or currently has an auto-immune disease.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
United States, Illinois
Chicago, Illinois, 60611
United States, Florida
Coral Gables, Florida, 33146
United States, California
Encino, California, 91436
United States, Santa Monica
Santa Monica, California, 90212
About this study
Official title: A Randomized, Blinded Evaluator, No-treatment Control, Multicenter, Prospective Clinical Study of RHA® Redensity Eye for the Treatment of Moderate to Severe Tissue Volume Deficiencies in the Infraorbital Regions
This is a multicenter, blinded evaluator, randomized, prospective, no treatment control clinical study to identify whether RHA® Redensity Eye (*) is superior to no treatment for the correction of moderate to severe tissue volume deficiencies in the infraorbital regions.
The study will include at least 20% of subjects with Fitzpatrick skin types IV-VI.
Read more
The Treating Investigator (TI) and the Blinded Live Evaluator (BLE) will evaluate the subject's infraorbital hollows independently of each other using the Teoxane Infraorbital Hollows Scale (TIOHS) at Screening (Visit 1) for eligibility.
If the subject is eligible, the BLE's assessment will be used for the Baseline of the primary endpoint.
Enrolled subjects will be randomly assigned in a ratio of 3:1 at Screening (Visit 1) to receive RHA® Redensity Eye or to receive no treatment (No-treatment control group).
Subjects receiving RHA® Redensity Eye will be further divided by the method of administration (i.e. injection with a 30G ½" needle or 25G 1 ½" cannula), which will be defined for each site at the beginning of the study. Site selection will aim to achieve approximately 1:1 distribution between the administration method subgroups. The BLE will be blinded to the study groups (RHA® Redensity Eye group or No treatment control group).
For subjects randomly assigned to RHA® Redensity Eye group, the study will be conducted in 2 Phases - Phase 1a and Phase 2.
For subjects randomly assigned to No-treatment control group, the study will be conducted in 3 Phases - Phase 1a, Phase 1b and Phase 2.
The Phase 1b is not applicable for the subject assigned to the RHA® Redensity Eye group.
(*): TEO-RHA-1902 was conducted with RHA® Redensity Eye Lido, that contains Lidocaine.
Read the detailed description
Phase 1a:
Subjects who will be randomly assigned to the RHA® Redensity Eye group at Screening will receive their injection at Visit 1. Subjects will come to the site 12 weeks (primary endpoint) after the initial treatment. Afterwards, subjects will proceed directly to Phase 2.
Subjects randomly assigned to the No-treatment control group at Screening will receive no treatment in Phase 1a of the study. They will come to the site 12 weeks (primary endpoint) after randomization. After completing all assessments, subjects will immediately begin Phase 1b (Visit 1b is on the same day as Visit at Week 12) and will receive their initial treatment with RHA® Redensity Eye.
Phase 1b:
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group. Once all evaluations applicable for Visit at Week 12 are completed, subjects will proceed directly to Visit 1b (on the same day). Evaluations completed at Week 12 will be used for Visit 1b and will become the new Baseline for Phase 1b.
Subjects will receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects will follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye will be administered on the same day (Visit 1b). Subjects will come to the site 12 weeks after their initial treatment. Afterwards, subjects will proceed to Phase 2.
Phase 2 and Exit visit:
Phase 2 will occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group (after Phase 1b).
All these subjects will come to the site 24 weeks, and 52 weeks after their initial treatment. All subjects will be followed for 52 weeks after their initial treatment with RHA® Redensity Eye.
Subjects will be offered retreatment (52 weeks after their initial treatment). Retreatment will be administered if the TI deems it to be appropriate and the subject agrees. If the subject does not receive retreatment, Visit at 52 weeks after initial treatment will become the Exit visit.
If the subject receives retreatment, the subjects will come to the site 12 weeks after retreatment for follow-up and safety assessments. This will be the Exit visit.
- Conditions
- Infra-orbital Hollows, Tear-trough Deformity, Wrinkle
- Being tested
- RHA® Redensity Eye
- Keywords
- Dermal Filler, Hyaluronic acid, Infra-orbital Hollows, Tear-trough deformity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RHA® Redensity EyeDevice
A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
| Study group | Role | What they receive |
|---|---|---|
| RHA® Redensity Eye Group | Experimental | RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided. Receives: Device: RHA® Redensity Eye |
| No-Treatment Control First, Then RHA Redensity Eye Treatment Group | No intervention | During Phase 1a, participants from No-treatment control group do not receive treatment. Primary endpoint assessments are done at Week 12. Once all evaluations applicable for Primary Endpoint at Week 12 are completed, subjects proceed directly to Phase 1b (on the same day). Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group. Phase 1b: Subjects receive their initial treatment with RHA® Redensity Eye at Visit 1b. Subjects follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye is administered on the same day (Visit 1b). Subjects come to the site 12 weeks after their initial treatment. RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow. Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 1 Point From Baseline in Infra-Orbital Hollows Severity Rated by the Blinded Live Evaluator (BLE) at Week 12 After Last Treatment, Using the TIOHS - Phase 1a
The TIOHS is a validated 5-point scale for assessing Infra-orbital hollows severity. Possible scores range from 0 (Absent) to 4 (Very Severe).
Change = (Week 12 - Baseline score). A TIOHS change of 1-grade will be considered clinically significant. Phase 1a: Subjects are randomly assigned to the RHA® Redensity Eye group or to the to the No-treatment control group, and come to the site 12 weeks (primary endpoint) after randomization.
Measured: Period 1 - Phase 1a: Week 12 after last treatment
The Modified FACE-Q "Appearance of Lower Eyelids" Change From Baseline Score for Subjects Treated With RHA® Redensity at Week 12 After Last Treatment - Phase 1a
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.
The modified FACE-Q questionnaire is composed of 4 questions with a score linked to answers (1 being "Not at all" and 4 being "Extremely").
To calculate the FACE-Q score, outcomes from all 4 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units (i.e. worst/lowest score = 0, best/highest score = 100).
Phase 1a: Subjects are randomly assigned to the RHA® Redensity Eye group or to the to the No-treatment control group, and come to the site 12 weeks (primary endpoint) after randomization.
Measured: Period 1 - Phase 1a: Change from Baseline at Week 12 after last treatment
Secondary outcomes (5)
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Subject at Weeks 12, 24, 52 After Last Treatment and at Week 12 After Retreatment - Phase 2
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".
The GAI will be assessed using the pre-injection baseline photograph. Phase 3 - Phase 2: Subjects from No-Treatment group receive their treatment with RHA® Redensity Eye following primary endpoint assessment, and enter into Phase 2. Phase 2 occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group, data are pooled for analysis.
Measured: Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after last treatment and at Week 12 after retreatment.
Number of Subjects Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 12, 24, 52 After Last Treatment and at Week 12 After Retreatment - Phase 2
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".
The GAI will be assessed using the pre-injection baseline photograph. Phase 2: Subjects from No-Treatment group receive their teatment with RHA® Redensity Eye following primary endpoint assessment, and enter into Phase 2. Phase 2 occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group, data are pooled for analysis.
Measured: Period 3 - Phase 2 - ITT population - Weeks 12, 24, 52 after last treatment and at Week 12 after retreatment.
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment - Phase 2
The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied).
Period 3 - Phase 2: Subjects from No-Treatment group receive their teatment with RHA® Redensity Eye following primary endpoint assessment, and enter into Phase 2. Phase 2 occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group, data are pooled for analysis.
Measured: Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after initial treatment and at Week 12 after retreatment.
Change of 1 Point From Baseline in Infra-Orbital Hollows Severity Rated by the Blinded Live Evaluator (BLE) at Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment Using the TIOHS - Phase 2
The TIOHS is a validated 5-point scale for assessing Infra-orbital hollows severity. Possible scores range from 0 (Absent) to 4 (Very Severe).
Period 3 - Phase 2: Subjects from No-Treatment group receive their teatment with RHA® Redensity Eye following primary endpoint assessment, and enter into Phase 2. Phase 2 occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group, data are pooled for analysis.
Measured: Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after initial treatment and at Week 12 after retreatment.
Subject's Perception of Treatment Effectiveness as Per the "Appearance of Lower Eyelids " FACE-Q Scale Questionnaire at Baseline, Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment - Phase 2
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.
The FACE-Q questionnaire is composed of 7 questions with a score linked to answers (1 being "Not at all" and 4 being "Extremely").
To calculate the FACE-Q score, outcomes from all 7 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units (i.e. worst/lowest score = 0, best/highest score = 100).
Period 3 - Phase 2: Subjects from No-Treatment group receive their teatment with RHA® Redensity Eye following primary endpoint assessment, and enter into Phase 2. Phase 2 occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group, data are pooled for analysis.
Measured: Period 3: Phase 2 - ITT population - Change from Baseline at Weeks 12, 24, 52 after initial treatment and at Week 12 after retreatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start2 Dec 2020
- Primary completion16 May 2023
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infra-orbital 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
- 248 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
- NCT04577898
- Sponsor's protocol ID
- TEO-RHA-1902
- Status last verified
- Jan 2026
- First submitted
- 28 Sep 2020
- Last updated
- 26 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded Evaluator, No-treatment Control, Multicenter, Prospective Clinical Study of RHA® Redensity Eye for the Treatment of Moderate to Severe Tissue Volume Deficiencies in the Infraorbital Regions
- ClinicalTrials.gov ID
- NCT04577898
- Acronym / sponsor ID
- TEO-RHA-1902
- Conditions
- Infra-orbital Hollows, Tear-trough Deformity, Wrinkle
- Keywords
- Dermal Filler, Hyaluronic acid, Infra-orbital Hollows, Tear-trough deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Teoxane SAIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Posted 26 Jan 2026
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 multicenter, blinded evaluator, randomized, prospective, no treatment control clinical study to identify whether RHA® Redensity Eye (*) is superior to no treatment for the correction of moderate to severe tissue volume deficiencies in the infraorbital regions.
The study will include at least 20% of subjects with Fitzpatrick skin types IV-VI.
The Treating Investigator (TI) and the Blinded Live Evaluator (BLE) will evaluate the subject's infraorbital hollows independently of each other using the Teoxane Infraorbital Hollows Scale (TIOHS) at Screening (Visit 1) for eligibility.
If the subject is eligible, the BLE's assessment will be used for the Baseline of the primary endpoint.
Enrolled subjects will be randomly assigned in a ratio of 3:1 at Screening (Visit 1) to receive RHA® Redensity Eye or to receive no treatment (No-treatment control group).
Subjects receiving RHA® Redensity Eye will be further divided by the method of administration (i.e. injection with a 30G ½" needle or 25G 1 ½" cannula), which will be defined for each site at the beginning of the study. Site selection will aim to achieve approximately 1:1 distribution between the administration method subgroups. The BLE will be blinded to the study groups (RHA® Redensity Eye group or No treatment control group).
For subjects randomly assigned to RHA® Redensity Eye group, the study will be conducted in 2 Phases - Phase 1a and Phase 2.
For subjects randomly assigned to No-treatment control group, the study will be conducted in 3 Phases - Phase 1a, Phase 1b and Phase 2.
The Phase 1b is not applicable for the subject assigned to the RHA® Redensity Eye group.
(*): TEO-RHA-1902 was conducted with RHA® Redensity Eye Lido, that contains Lidocaine.
Detailed description
Phase 1a:
Subjects who will be randomly assigned to the RHA® Redensity Eye group at Screening will receive their injection at Visit 1. Subjects will come to the site 12 weeks (primary endpoint) after the initial treatment. Afterwards, subjects will proceed directly to Phase 2.
Subjects randomly assigned to the No-treatment control group at Screening will receive no treatment in Phase 1a of the study. They will come to the site 12 weeks (primary endpoint) after randomization. After completing all assessments, subjects will immediately begin Phase 1b (Visit 1b is on the same day as Visit at Week 12) and will receive their initial treatment with RHA® Redensity Eye.
Phase 1b:
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group. Once all evaluations applicable for Visit at Week 12 are completed, subjects will proceed directly to Visit 1b (on the same day). Evaluations completed at Week 12 will be used for Visit 1b and will become the new Baseline for Phase 1b.
Subjects will receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects will follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye will be administered on the same day (Visit 1b). Subjects will come to the site 12 weeks after their initial treatment. Afterwards, subjects will proceed to Phase 2.
Phase 2 and Exit visit:
Phase 2 will occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group (after Phase 1b).
All these subjects will come to the site 24 weeks, and 52 weeks after their initial treatment. All subjects will be followed for 52 weeks after their initial treatment with RHA® Redensity Eye.
Subjects will be offered retreatment (52 weeks after their initial treatment). Retreatment will be administered if the TI deems it to be appropriate and the subject agrees. If the subject does not receive retreatment, Visit at 52 weeks after initial treatment will become the Exit visit.
If the subject receives retreatment, the subjects will come to the site 12 weeks after retreatment for follow-up and safety assessments. This will be the Exit visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RHA® Redensity Eye Group | Experimental | Device: RHA® Redensity EyeRHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow. Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided. |
| No-Treatment Control First, Then RHA Redensity Eye Treatment Group | No intervention | –During Phase 1a, participants from No-treatment control group do not receive treatment. Primary endpoint assessments are done at Week 12. Once all evaluations applicable for Primary Endpoint at Week 12 are completed, subjects proceed directly to Phase 1b (on the same day). Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group. Phase 1b: Subjects receive their initial treatment with RHA® Redensity Eye at Visit 1b. Subjects follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye is administered on the same day (Visit 1b). Subjects come to the site 12 weeks after their initial treatment. RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow. Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatient, male or female of any race, 22 years of age or older
- Infra-orbital Hollows of grade 2 to 3 on the TIOHS (ranging from 0 to 4) who is seeking treatment of moderate to severe tissue volume deficiencies in the infra-orbital region (realistic and achievable as per TI opinion). Bilateral symmetry is not required. If the assessments of the TI and the BLE are the same or differ by exactly 1 point on the scale, this difference is considered acceptable. If the subject is eligible, the BLE's assessment will be used for the Baseline for the primary endpoint. If the TI and the BLE do not agree on eligibility, or if their assessments differ by 2 points or more on the scale, the subject will not be eligible.
- Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
- Able to follow study instructions and complete all required visits.
- Sign the IRB-approved ICF, Photographic Release Form and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study- related procedures being performed.
Key exclusion criteria (4 listed)
- Female subjects that are pregnant, breast-feeding or of childbearing potential and not practicing reliable birth control
- Known hypersensitivity/allergy to any component of the study devices
- Clinically significant active skin disease within 6 months
- Has a history of or currently has an auto-immune disease.
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 |
|---|---|---|
| RHA® Redensity EyeA sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer. | Device | RHA® Redensity Eye Group |
Primary outcome
Change of 1 Point From Baseline in Infra-Orbital Hollows Severity Rated by the Blinded Live Evaluator (BLE) at Week 12 After Last Treatment, Using the TIOHS - Phase 1a
Time frame: Period 1 - Phase 1a: Week 12 after last treatment
The TIOHS is a validated 5-point scale for assessing Infra-orbital hollows severity. Possible scores range from 0 (Absent) to 4 (Very Severe). Change = (Week 12 - Baseline score). A TIOHS change of 1-grade will be considered clinically significant. Phase 1a: Subjects are randomly assigned to the RHA® Redensity Eye group or to the to the No-treatment control group, and come to the site 12 weeks (primary endpoint) after randomization.
The Modified FACE-Q "Appearance of Lower Eyelids" Change From Baseline Score for Subjects Treated With RHA® Redensity at Week 12 After Last Treatment - Phase 1a
Time frame: Period 1 - Phase 1a: Change from Baseline at Week 12 after last treatment
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The modified FACE-Q questionnaire is composed of 4 questions with a score linked to answers (1 being "Not at all" and 4 being "Extremely"). To calculate the FACE-Q score, outcomes from all 4 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units (i.e. worst/lowest score = 0, best/highest score = 100). Phase 1a: Subjects are randomly assigned to the RHA® Redensity Eye group or to the to the No-treatment control group, and come to the site 12 weeks (primary endpoint) after randomization.
5 secondary outcomes
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Subject at Weeks 12, 24, 52 After Last Treatment and at Week 12 After Retreatment - Phase 2
Time frame: Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after last treatment and at Week 12 after retreatment.
Number of Subjects Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 12, 24, 52 After Last Treatment and at Week 12 After Retreatment - Phase 2
Time frame: Period 3 - Phase 2 - ITT population - Weeks 12, 24, 52 after last treatment and at Week 12 after retreatment.
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment - Phase 2
Time frame: Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after initial treatment and at Week 12 after retreatment.
Change of 1 Point From Baseline in Infra-Orbital Hollows Severity Rated by the Blinded Live Evaluator (BLE) at Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment Using the TIOHS - Phase 2
Time frame: Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after initial treatment and at Week 12 after retreatment.
Subject's Perception of Treatment Effectiveness as Per the "Appearance of Lower Eyelids " FACE-Q Scale Questionnaire at Baseline, Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment - Phase 2
Time frame: Period 3: Phase 2 - ITT population - Change from Baseline at Weeks 12, 24, 52 after initial treatment and at Week 12 after retreatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RHA® Redensity Eye in people with Infra-orbital Hollows and Tear-trough Deformity, run by Teoxane SA at 4 sites in United States.
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 5 inclusion and 4 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 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of 1 Point From Baseline in Infra-Orbital Hollows Severity Rated by the Blinded Live Evaluator (BLE) at Week 12 After Last Treatment, Using the TIOHS - Phase 1a (time frame: Period 1 - Phase 1a: Week 12 after last treatment). The study lists 2 primary outcomes in all. 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 26 Jan 2026.