WrinkleNCT04754646
RHA® 4 NLF Cannula
A study testing Split-face injection of RHA® 4 with a cannula into a single NLF. and Split-face injection of RHA® 4 with a needle (TSK 27G x ½") into the contralateral NLF. in people with Wrinkle and Nasolabial Fold, run by Teoxane SA at 4 sites in United States.
Trial summary
This is a randomized, controlled, single-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA®4 injected in NLFs with a cannula is non-inferior to RHA®4 injected in NLFs with a sharp needle (27G x ½") for the correction of moderate to severe NLFs as determined by the Blinded… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Nasolabial Fold, Aging
- What is being tested?
- Split-face injection of RHA® 4 with a cannula into a single NLF. and Split-face injection of RHA® 4 with a needle (TSK 27G x ½") into the contralateral NLF.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Mar 2021to 29 Nov 2021
- 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.
- Female subjects of childbearing potential must have a negative UPT and practice a reliable method of contraception throughout the study.
- Moderate to severe bilateral nasolabial folds (grade 3 or 4 on the five-point NLF-WSRS). BLE and TI must independently agree that the criterion is met; however, strict concordance of severity not required. BLE assessments will be used for the primary endpoint. If TI and BLE do not agree on eligibility, or if their assessments differ by ≥2 grades, the subject will not be eligible.
- Nasolabial folds of the same NLF-WSRS grade on the left and right sides of the face.
- Willing to abstain from facial aesthetic procedures/therapies that could interfere with the study evaluations.
- Able to follow study instructions and complete all required visits.
- Sign the IRB-approved ICF, Photographic Release Form, the Authorization for Use and release of Health and Research Study Information (HIPAA) form, and if applicable, the California Experimental Research Subject's Bill of Rights prior to any study-related procedures being performed.
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.
- Malignancy (excluding non-melanoma skin cancer) within the past 5 years.
- History of skin cancer in the treatment area.
Show all 9Show fewer
- Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
- Exposure to any other investigational drug/device within 90 days of entering the study or planning to participate in another investigation during the course of the study.
- Study staff or close relative to study staff (e.g., parents, children, siblings, or spouse)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
United States, North Carolina
Chapel Hill, North Carolina, 27517
United States, California
Encinitas, California, 92024
United States, Tennessee
Nashville, Tennessee, 37203
United States, Florida
West Palm Beach, Florida, 33401
About this study
Official title: A Randomized, Controlled, Single-blinded, Within-subject (Split-face), Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Using the Dermal Filler RHA®4 Injected With a Cannula or With a Sharp Needle for the Treatment of Moderate to Severe Nasolabial Folds
This is a randomized, controlled, single-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA®4 injected in NLFs with a cannula is non-inferior to RHA®4 injected in NLFs with a sharp needle (27G x ½") for the correction of moderate to severe NLFs as determined by the Blinded Live Evaluator (BLE) using the Teoxyne NLF-WSRS (proprietary, validated NLF Wrinkle Severity Rating Scale) at 12 weeks from last treatment.
At Visit 1 (Week 0), RHA®4 injected with cannula will be administered in a random sequence (first or second injection) and side of the face (left or right NLF) and RHA®4 injected with a sharp needle will be administered to the other side. The TI will administer study devices and will be unblinded to treatment allocation. Blinded assessments of effectiveness will be conducted by the BLE (Blinded Live Evaluator).
Read more
4 weeks following initial treatment, subjects will attend Visit 2 and receive, if necessary, touch-up treatments (using a needle or cannula as per the subject's initial treatment assignment).
Subjects receiving touch-up treatments at Week 4 (Visit 2) will attend a new Visit 2b (4 weeks following touch-up treatment); subject not receiving touch-up treatment will not attend Visit 2b.
After each injection (initial treatment or touch-up), subjects will receive a safety follow-up call from the study site within 3-day.
Subjects will then attend scheduled in-office study visits at 8 (Visit 3) and 12 weeks (Visit 4) following last treatment (initial treatment or touch-up) where safety and effectiveness assessments will be conducted.
- Conditions
- Wrinkle, Nasolabial Fold, Aging
- Being tested
- Split-face injection of RHA® 4 with a cannula into a single NLF., Split-face injection of RHA® 4 with a needle (TSK 27G x ½") into the contralateral NLF.
- Keywords
- Dermal Filler, Hyaluronic acid, Cannula, Nasolabial folds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split-face injection of RHA® 4 with a cannula into a single NLF.Device
RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.
Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
The brand of cannula used for injection is up to the discretion of the Treating Investigator (TI), providing the cannula is registered for use by the US FDA.
Split-face injection of RHA® 4 with a needle (TSK 27G x ½") into the contralateral NLF.Device
RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.
Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
| Study group | Role | What they receive |
|---|---|---|
| RHA®4 - Cannula | Experimental | Not described Receives: Device: Split-face injection of RHA® 4 with a cannula into a single NLF. |
| RHA®4 - Needle | Active comparator | Not described Receives: Device: Split-face injection of RHA® 4 with a needle (TSK 27G x ½") into the contralateral NLF. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NLF-WSRS Score Between Baseline and Week 12 After Last Treatment as Assessed by the BLE
Non-inferiority of RHA®4 injected with a cannula to the change from Baseline for subjects treated with RHA®4 injected with a needle at 12 weeks after last treatment (initial or touch-up; up to 16 weeks post-baseline)) as assessed by the BLE using the NLF-WSRS.
NLF-WSRS (Nasolabial Folds - Wrinkle Severity Rating Scale) is a proprietary validated 5-grade scale with 1 being "Absent" and 5 being "Extreme".
An NLF-WSRS change of >1 grade will be considered clinically significant.
Measured: Week 12 after last treatment
Secondary outcomes (16)
Change in Score From Baseline in the Nasolabial Folds Severity Rated by the Treating Investigator (TI) at Weeks 4, 8 and 12 After Last Treatment Using the NLF-WSRS.
NLF-WSRS (Nasolabial Folds - Wrinkle Severity Rating Scale) is a proprietary validated 5-grade scale with 1 being "Absent" and 5 being "Extreme".
Measured: Weeks 4, 8 and 12 after last treatment
Number of Responders (Change of ≥1-grade From Baseline in the Naso-labial Folds Severity) as Assessed by the Blinded Live Evaluator (BLE) at Week 12 After Last Treatment Using the NLF-WSRS.
NLF-WSRS (Nasolabial Folds- Wrinkle Severity Rating Scale) is a proprietary validated 5-grade scale with 1 being "Absent" and 5 being "Extreme".
Measured: Week 12 after last treatment
Number of Responders (Change of ≥1-grade From Baseline in the Naso-labial Folds Severity) as Assessed by the Treating Investigator (TI) at Weeks 4, 8 and 12 After Last Treatment Using the NLF-WSRS.
NLF-WSRS (Nasolabial Folds- Wrinkle Severity Rating Scale) is a validated 5-grade scale with 1 being "Absent" and 5 being "Extreme"
Measured: Weeks 4, 8 and 12 after last treatment
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at 12 Weeks Following Last Treatment.
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. Each side of the face will be assessed independently.
Measured: Week 12 after last treatment
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at 4, 8 and 12 Weeks Following Last Treatment.
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. Each side of the face will be assessed independently.
Measured: Weeks 4, 8 and 12 after last treatment
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at 4, 8 and 12 Weeks Following Last Treatment.
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. Each side of the face was assessed independently.
Subjects will be instructed: "Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale".
Measured: Weeks 4, 8 and 12 after last treatment
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at 4, 8 and 12 Weeks Following Last Treatment.
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).
Measured: Weeks 4, 8 and 12 after last treatment
Subject's Perception of Treatment Effectiveness as Per the FACE-Q | Aesthetics© (Nasolabial Folds Domain) Questionnaire. The FACE-Q Measures the Experience and Outcomes of Aesthetic Facial Procedures From the Patient's Perspective.
The FACE-Q | Aesthetics© questionnaire is composed of 5 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely').
The subject will be instructed as follows: "These questions ask about how you look right now. For each question, circle only one answer. With your nasolabial folds in mind (the deep lines that run downward from the sides of your nose), in the past week, how much have you been bothered by:", and will provide response.
To calculate the FACE-Q, outcomes from all 5 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).
Measured: Weeks 4, 8 and 12 after last treatment
Number of Participants Receiving Initial and Touch-Up Treatment Sessions to Obtain an Optimal Cosmetic Results as Judged by the Treating Investigator
Number of subjects receiving treatment (initial and touch up)
Measured: Baseline (Week 0, Visit 1) and Touch-up (Week 4, Visit 2)
Total Volume Per NLF to Obtain an Optimal Cosmetic Results as Judged by the Treating Investigator.
Measured: Baseline (Week 0) and Touch-up (Week 4)
NLF Symmetry as Assessed by the Blinded-live Evaluator at Baseline and 12 Weeks Following Last Treatment.
NLF symmetry will be assessed for right and left NLF by answering the question "Are the NLFs symmetric or asymmetric?" (answer = symmetric or asymmetric answer). If asymmetric, the asymmetry will be further assessed as mild, moderate or severe.
Measured: Baseline (Week 0) and Week 12 after last treatment
NLF Symmetry as Assessed by the Treating Investigator at Baseline 4, 8 and 12 Weeks Following Last Treatment.
NLF symmetry will be assessed by the TI for right and left NLF by answering the question "Are the NLFs symmetric or asymmetric?" (answer = symmetric or asymmetric answer). If asymmetric, the asymmetry will be further assessed as mild, moderate or severe.
Measured: Weeks 4, 8 and 12 after last treatment
NLF Symmetry as Assessed by the Subject at Baseline, 4, 8 and 12 Weeks Following Last Treatment.
NLF symmetry will be assessed for right and left NLF by answering the question "Are the NLFs symmetric or asymmetric?" (answer = symmetric or asymmetric answer). If asymmetric, the asymmetry will be further assessed as mild, moderate or severe.
Measured: Weeks 4, 8 and 12 after last treatment
Number of Participants With Adverse Events (AEs) for the Safety Evaluation of RHA® 4
The Treating Investigator will assess adverse events and record details of seriousness, severity, duration, and action taken with the study device, and relationship to the study device. AEs will be reported from the time of consent until week 12 of the last treatment.
An AE is any untoward medical occurrence in a subject administered the study device and which may, but does not necessarily, have a causal relationship with the device. An AE can therefore be any unfavorable or unintended sign (for example an abnormal laboratory finding), symptom or disease temporally associated with the use the study device, whether or not considered related to that device.
Measured: Baseline through Week 12 after last treatment
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of RHA® 4.
The subjects will receive a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 28 days after treatment. The diary will be discussed during telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm).
The subject diary captures the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and "other".
The 28-day patient CTR diary includes a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate "other" if the subject experienced a sign/symptom that is not listed.
The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR).
Measured: During 28 days after initial treatment and touch-up, so a total of 42 days post-baseline if the subject received a touch-up
Assessment at Each Injection Visit (Initial Inejction and Touch-up) of Injection Site Pain Felt by the Patient for the Safety Evaluation of RHA® 4 Immediately After Treatment, and at 5, 30, and 60 Minutes Post-treatment
The Injection Site Pain (during injection and post-injection) will be self-assessed by the subject using a 100 mm Visual Analog Scale (VAS). VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain.
Measured: Immediately after treatment, and at 5, 30, and 60 minutes post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start15 Mar 2021
- Primary completion17 Aug 2021
- Study completion29 Nov 2021
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 WrinkleStudies 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
- 50 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
- NCT04754646
- Sponsor's protocol ID
- TEO-RHA-2001
- Status last verified
- Mar 2023
- First submitted
- 8 Feb 2021
- Last updated
- 9 Mar 2023
- 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 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Single-blinded, Within-subject (Split-face), Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Using the Dermal Filler RHA®4 Injected With a Cannula or With a Sharp Needle for the Treatment of Moderate to Severe Nasolabial Folds
- ClinicalTrials.gov ID
- NCT04754646
- Acronym / sponsor ID
- TEO-RHA-2001
- Conditions
- Wrinkle, Nasolabial Fold, Aging
- Keywords
- Dermal Filler, Hyaluronic acid, Cannula, Nasolabial folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Teoxane SAIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Posted 9 Mar 2023
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 randomized, controlled, single-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA®4 injected in NLFs with a cannula is non-inferior to RHA®4 injected in NLFs with a sharp needle (27G x ½") for the correction of moderate to severe NLFs as determined by the Blinded Live Evaluator (BLE) using the Teoxyne NLF-WSRS (proprietary, validated NLF Wrinkle Severity Rating Scale) at 12 weeks from last treatment.
At Visit 1 (Week 0), RHA®4 injected with cannula will be administered in a random sequence (first or second injection) and side of the face (left or right NLF) and RHA®4 injected with a sharp needle will be administered to the other side. The TI will administer study devices and will be unblinded to treatment allocation. Blinded assessments of effectiveness will be conducted by the BLE (Blinded Live Evaluator).
4 weeks following initial treatment, subjects will attend Visit 2 and receive, if necessary, touch-up treatments (using a needle or cannula as per the subject's initial treatment assignment).
Subjects receiving touch-up treatments at Week 4 (Visit 2) will attend a new Visit 2b (4 weeks following touch-up treatment); subject not receiving touch-up treatment will not attend Visit 2b.
After each injection (initial treatment or touch-up), subjects will receive a safety follow-up call from the study site within 3-day.
Subjects will then attend scheduled in-office study visits at 8 (Visit 3) and 12 weeks (Visit 4) following last treatment (initial treatment or touch-up) where safety and effectiveness assessments will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RHA®4 - Cannula | Experimental | Device: Split-face injection of RHA® 4 with a cannula into a single NLF. |
| RHA®4 - Needle | Active comparator | Device: Split-face injection of RHA® 4 with a needle (TSK 27G x ½") into the contralateral NLF. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Outpatient, male or female of any race, 22 years of age or older.
- Female subjects of childbearing potential must have a negative UPT and practice a reliable method of contraception throughout the study.
- Moderate to severe bilateral nasolabial folds (grade 3 or 4 on the five-point NLF-WSRS). BLE and TI must independently agree that the criterion is met; however, strict concordance of severity not required. BLE assessments will be used for the primary endpoint. If TI and BLE do not agree on eligibility, or if their assessments differ by ≥2 grades, the subject will not be eligible.
- Nasolabial folds of the same NLF-WSRS grade on the left and right sides of the face.
- Willing to abstain from facial aesthetic procedures/therapies that could interfere with the 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.
- History of connective tissue disease.
- Malignancy (excluding non-melanoma skin cancer) within the past 5 years.
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 |
|---|---|---|
| Split-face injection of RHA® 4 with a cannula into a single NLF.RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF). The brand of cannula used for injection is up to the discretion of the Treating Investigator (TI), providing the cannula is registered for use by the US FDA. | Device | RHA®4 - Cannula |
| Split-face injection of RHA® 4 with a needle (TSK 27G x ½") into the contralateral NLF.RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF). | Device | RHA®4 - Needle |
Primary outcome
Change in NLF-WSRS Score Between Baseline and Week 12 After Last Treatment as Assessed by the BLE
Time frame: Week 12 after last treatment
Non-inferiority of RHA®4 injected with a cannula to the change from Baseline for subjects treated with RHA®4 injected with a needle at 12 weeks after last treatment (initial or touch-up; up to 16 weeks post-baseline)) as assessed by the BLE using the NLF-WSRS. NLF-WSRS (Nasolabial Folds - Wrinkle Severity Rating Scale) is a proprietary validated 5-grade scale with 1 being "Absent" and 5 being "Extreme". An NLF-WSRS change of >1 grade will be considered clinically significant.
16 secondary outcomes
Change in Score From Baseline in the Nasolabial Folds Severity Rated by the Treating Investigator (TI) at Weeks 4, 8 and 12 After Last Treatment Using the NLF-WSRS.
Time frame: Weeks 4, 8 and 12 after last treatment
Number of Responders (Change of ≥1-grade From Baseline in the Naso-labial Folds Severity) as Assessed by the Blinded Live Evaluator (BLE) at Week 12 After Last Treatment Using the NLF-WSRS.
Time frame: Week 12 after last treatment
Number of Responders (Change of ≥1-grade From Baseline in the Naso-labial Folds Severity) as Assessed by the Treating Investigator (TI) at Weeks 4, 8 and 12 After Last Treatment Using the NLF-WSRS.
Time frame: Weeks 4, 8 and 12 after last treatment
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at 12 Weeks Following Last Treatment.
Time frame: Week 12 after last treatment
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at 4, 8 and 12 Weeks Following Last Treatment.
Time frame: Weeks 4, 8 and 12 after last treatment
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at 4, 8 and 12 Weeks Following Last Treatment.
Time frame: Weeks 4, 8 and 12 after last treatment
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at 4, 8 and 12 Weeks Following Last Treatment.
Time frame: Weeks 4, 8 and 12 after last treatment
Subject's Perception of Treatment Effectiveness as Per the FACE-Q | Aesthetics© (Nasolabial Folds Domain) Questionnaire. The FACE-Q Measures the Experience and Outcomes of Aesthetic Facial Procedures From the Patient's Perspective.
Time frame: Weeks 4, 8 and 12 after last treatment
Number of Participants Receiving Initial and Touch-Up Treatment Sessions to Obtain an Optimal Cosmetic Results as Judged by the Treating Investigator
Time frame: Baseline (Week 0, Visit 1) and Touch-up (Week 4, Visit 2)
Total Volume Per NLF to Obtain an Optimal Cosmetic Results as Judged by the Treating Investigator.
Time frame: Baseline (Week 0) and Touch-up (Week 4)
NLF Symmetry as Assessed by the Blinded-live Evaluator at Baseline and 12 Weeks Following Last Treatment.
Time frame: Baseline (Week 0) and Week 12 after last treatment
NLF Symmetry as Assessed by the Treating Investigator at Baseline 4, 8 and 12 Weeks Following Last Treatment.
Time frame: Weeks 4, 8 and 12 after last treatment
NLF Symmetry as Assessed by the Subject at Baseline, 4, 8 and 12 Weeks Following Last Treatment.
Time frame: Weeks 4, 8 and 12 after last treatment
Number of Participants With Adverse Events (AEs) for the Safety Evaluation of RHA® 4
Time frame: Baseline through Week 12 after last treatment
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of RHA® 4.
Time frame: During 28 days after initial treatment and touch-up, so a total of 42 days post-baseline if the subject received a touch-up
Assessment at Each Injection Visit (Initial Inejction and Touch-up) of Injection Site Pain Felt by the Patient for the Safety Evaluation of RHA® 4 Immediately After Treatment, and at 5, 30, and 60 Minutes Post-treatment
Time frame: Immediately after treatment, and at 5, 30, and 60 minutes post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- 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 Split-face injection of RHA® 4 with a cannula into a single NLF. and Split-face injection of RHA® 4 with a needle (TSK 27G x ½") into the contralateral NLF. in people with Wrinkle and Nasolabial Fold, 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 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: finished, as of the sponsor's last update on 9 Mar 2023. 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 9 Mar 2023). 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 in NLF-WSRS Score Between Baseline and Week 12 After Last Treatment as Assessed by the BLE (time frame: Week 12 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 9 Mar 2023.