Lip AugmentationNCT04540913
RHA® 3 Versus Restylane-L® for Lip Augmentation
A study testing RHA 3 and Restylane-L in people with Lip Augmentation and Lip, run by Teoxane SA at 1 site in United States.
Trial summary
This is a multicenter, double-blinded, randomized, prospective, controlled clinical study to identify whether RHA® 3 is non-inferior to Restylane-L® for lip augmentation at Week 12 after the last treatment (initial or touch-up). Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lip Augmentation, Lip
- What is being tested?
- RHA 3 and Restylane-L
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2020to 7 Sep 2022
- 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
- Lip fullness of grade 1 to 3 on the TLFS (ranging from 1 to 5) who desire at least 1 point of correction for upper and/or lower lips OR has Fitzpatrick skin type V or VI and has lip fullness grade 4 or 5 on the TLFS who desire treatment to the vermillion body for upper and/or lower lips. The BLE and TI must independently assess and agree that this criterion is met; however, concordance of fullness 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 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
1 site in 1 country.
About this study
Official title: A Controlled, Randomized, Double-blinded, Between-subject, Multicenter, Prospective Clinical Study to Evaluate Safety and Effectiveness of RHA® 3 Versus Restylane-L® for Lip Augmentation
This is a multicenter, double-blinded, randomized, prospective, controlled clinical study to identify whether RHA® 3 is non-inferior to Restylane-L® for lip augmentation at Week 12 after the last treatment (initial or touch-up).
At screening, the treating investigator (TI) will evaluate the subject's lip fullness using the validated Teoxane Lip Fullness Scale (5-grade) for eligibility of the subject for the study.
Read more
At screening, the blinded live evaluator (BLE) will evaluate the subject's lip fullness using the TLFS to confirm eligibility and to establish a pre-treatment score for assessment of effectiveness.
Enrolled subjects will be randomly assigned in a 3:1 ratio to either the RHA® 3 or the Restylane-L® treatment group. Subjects will be blinded to the study treatment. The TI will administer the fillers, and if necessary, subjects will receive a touch-up treatment 4 weeks after the initial treatment to optimize the results. If the touch-up treatment is administered, the subject will be asked to come to the site for an additional visit 4 weeks after the touch-up injection.
The study duration was extended from 36 to 52 weeks once all subjects had already been enrolled. Nearly 60% of the subjects consented to extend the study to 52 weeks before being eligible for repeat treatment. All data are presented up to 52 weeks (as well as 4 more weeks follow-up after retreatment at 36 or 52 weeks).
Subjects will be followed for 36 to 52 weeks after their last treatment (initial treatment or touch-up), at which point, they will be offered re-treatment with RHA® 3, regardless of their original treatment, provided that the TI deems the treatment to be appropriate and the subject agrees. Reasons for not administering the re-treatment will be documented.
The subject will then be followed for an additional 4 weeks before exiting the study. If the subject or the TI declines re-treatment, this visit (36 or 52 weeks after the last treatment) will be considered the study Exit visit.
For subjects with re-treatment, the Exit visit will be 4 weeks after the re-treatment.
The TI will conduct safety and effectiveness evaluations at each study visit (up to 36 weeks or 52 (if applicable) weeks after the last treatment, and 4 weeks after re treatment) or until all treatment-related ongoing adverse events (AEs) have resolved or resolved with sequelae as per TI judgment or if follow-up is no longer possible.
- Conditions
- Lip Augmentation, Lip
- Being tested
- RHA 3, Restylane-L
- Keywords
- Dermal Filler, Hyaluronic acid, Lip, Lip Augmentation
- Medical subject headings
- Lymphoid Interstitial Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RHA 3Device
Investigational Product, RHA® 3 is a viscoelastic, sterile, non-pyrogenic, clear, colorless, homogenous, and biodegradable gel implant. It is formulated with sodium hyaluronic acid (NaHA) at a concentration of 23 mg/g obtained from bacterial fermentation using the Streptococcus equi bacterial strained, crosslinked with 1,4 butanediol diglycidyl ether (BDDE) and reconstituted in a physiological buffer (pH 7.3). RHA® 3 also contains 0.3% lidocaine hydrochloride to reduce pain on injection.
Restylane-LDevice
Comparator Product, Restylane-L is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL with 0.3% lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| RHA 3 | Experimental | Injection of RHA 3 into into the vermillion body, vermillion border, and oral commissures of the lips (up to 3 ml with a max of 1.5 ml per lip), injected into the lip mucosa and/or mid to deep dermis as appropriate for lip augmentation.
Optional touch up treatment provided at 4 Weeks, optional retreatment at 36 or 52 Weeks. Receives: Device: RHA 3 |
| Restylane- L | Active comparator | Injection of Restylane- L into into the vermillion body, vermillion border, and oral commissures of the lips (up to 3 ml with a max of 1.5 ml per lip), injected into the lip mucosa and/or mid to deep dermis as appropriate for lip augmentation.
Optional touch up treatment provided at 4 Weeks. Receives: Device: Restylane-L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TLFS Score (Teoxane Lip Fullness Scale) Between Baseline and Week 12 After Last Treatment of RHA®3 Versus Control Device, as Assessed by the BLE
A change in the TLFS ≥1 grade compared to pre-treatment will be considered clinically meaningful.
The TLFS is a validated 5-point scale for assessing lip augmentation. Possible scores range from 1 (Very Thin) to 5 (Very Full).
Change = (Week 12 - Baseline score).
Measured: Week 12 after last treatment
Secondary outcomes (6)
Change From Baseline in TLFS Score as Assessed by the BLE at Visit 5 (Weeks 24 After Last Treatment), 6 (Weeks 36 After Last Treatment), 7 (Week 52 After Last Treatment) if Applicable, and Re-treatment (4 Weeks After Re-treatment)
A change in the TLFS ≥1 grade compared to pre-treatment will be considered clinically meaningful.
The TLFS is a validated 5-point static scale for assessing lip augmentation. Possible scores range from 1 (Very Thin) to 5 (Very Full).
Measured: Weeks 36 and 52 after last treatment, week 4 after re-treatment
Responder Rate Calculated Using TLFS Assessed by the BLE
A responder will be defined as a subject who has a ≥1 grade improvement on the TLFS.
The TLFS is a validated 5-point static scale for assessing lip augmentation. Possible scores range from 1 (Very Thin) to 5 (Very Full).
Measured: Weeks 12, 36, 52 after last treatment, week 4 after re-treatment
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 12, 36, 52 After Last Treatment and 4 Weeks After Re-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 12, 36, 52 after last treatment and 4 week after re-treatment.
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Lips" FACE-Q | Aesthetics© Scale Questionnaire at Weeks 12, 36, 52 After Last Treatment and 4 Week After Re-treatment.
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.
The FACE-Q questionnaire is composed of 10 questions with a score linked to answers (1 being "Very Dissatisfied" and 4 being "Very Satisfied").
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 lips in mind, in the past week, how satisfied or dissatisfied have been with:", and will provide response.
To calculate the FACE-Q, outcomes from all 10 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: Change from Baseline at Weeks 12, 36, 52 after last treatment and 4 week after re-treatment.
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Outcome" FACE-Q | Aesthetics© Scale Questionnaire at Weeks 12, 36, 52 After Last Treatment and 4 Week After Re-treatment.
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.
The FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being "Definitely disagree" and 4 being "Definitely agree").
The subject will be instructed as follows: "We would like to know how you feel about your most recent procedure. For each question, select only one answer. Please indicate how much you agree or disagree with each statement:", and will provide response.
To calculate the FACE-Q, outcomes from all 16questions 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 12, 36, 52 after last treatment and 4 week after re-treatment.
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the BLE.
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 baseline photograph.
Measured: Weeks 12, 36, 52 after last treatment, and 4 weeks after re-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start22 Oct 2020
- Primary completion11 May 2022
- Study completion7 Sep 2022
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 Lip AugmentationStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 202 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
- NCT04540913
- Sponsor's protocol ID
- TEO-RHA-1806
- Status last verified
- Jan 2025
- First submitted
- 28 Aug 2020
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Randomized, Double-blinded, Between-subject, Multicenter, Prospective Clinical Study to Evaluate Safety and Effectiveness of RHA® 3 Versus Restylane-L® for Lip Augmentation
- ClinicalTrials.gov ID
- NCT04540913
- Acronym / sponsor ID
- TEO-RHA-1806
- Conditions
- Lip Augmentation, Lip
- Keywords
- Dermal Filler, Hyaluronic acid, Lip, Lip Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Teoxane SAIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Posted 15 Dec 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 multicenter, double-blinded, randomized, prospective, controlled clinical study to identify whether RHA® 3 is non-inferior to Restylane-L® for lip augmentation at Week 12 after the last treatment (initial or touch-up).
At screening, the treating investigator (TI) will evaluate the subject's lip fullness using the validated Teoxane Lip Fullness Scale (5-grade) for eligibility of the subject for the study.
At screening, the blinded live evaluator (BLE) will evaluate the subject's lip fullness using the TLFS to confirm eligibility and to establish a pre-treatment score for assessment of effectiveness.
Enrolled subjects will be randomly assigned in a 3:1 ratio to either the RHA® 3 or the Restylane-L® treatment group. Subjects will be blinded to the study treatment. The TI will administer the fillers, and if necessary, subjects will receive a touch-up treatment 4 weeks after the initial treatment to optimize the results. If the touch-up treatment is administered, the subject will be asked to come to the site for an additional visit 4 weeks after the touch-up injection.
The study duration was extended from 36 to 52 weeks once all subjects had already been enrolled. Nearly 60% of the subjects consented to extend the study to 52 weeks before being eligible for repeat treatment. All data are presented up to 52 weeks (as well as 4 more weeks follow-up after retreatment at 36 or 52 weeks).
Subjects will be followed for 36 to 52 weeks after their last treatment (initial treatment or touch-up), at which point, they will be offered re-treatment with RHA® 3, regardless of their original treatment, provided that the TI deems the treatment to be appropriate and the subject agrees. Reasons for not administering the re-treatment will be documented.
The subject will then be followed for an additional 4 weeks before exiting the study. If the subject or the TI declines re-treatment, this visit (36 or 52 weeks after the last treatment) will be considered the study Exit visit.
For subjects with re-treatment, the Exit visit will be 4 weeks after the re-treatment.
The TI will conduct safety and effectiveness evaluations at each study visit (up to 36 weeks or 52 (if applicable) weeks after the last treatment, and 4 weeks after re treatment) or until all treatment-related ongoing adverse events (AEs) have resolved or resolved with sequelae as per TI judgment or if follow-up is no longer possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RHA 3 | Experimental | Device: RHA 3Injection of RHA 3 into into the vermillion body, vermillion border, and oral commissures of the lips (up to 3 ml with a max of 1.5 ml per lip), injected into the lip mucosa and/or mid to deep dermis as appropriate for lip augmentation. Optional touch up treatment provided at 4 Weeks, optional retreatment at 36 or 52 Weeks. |
| Restylane- L | Active comparator | Device: Restylane-LInjection of Restylane- L into into the vermillion body, vermillion border, and oral commissures of the lips (up to 3 ml with a max of 1.5 ml per lip), injected into the lip mucosa and/or mid to deep dermis as appropriate for lip augmentation. Optional touch up treatment provided at 4 Weeks. |
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
- Lip fullness of grade 1 to 3 on the TLFS (ranging from 1 to 5) who desire at least 1 point of correction for upper and/or lower lips OR has Fitzpatrick skin type V or VI and has lip fullness grade 4 or 5 on the TLFS who desire treatment to the vermillion body for upper and/or lower lips. The BLE and TI must independently assess and agree that this criterion is met; however, concordance of fullness 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 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 3Investigational Product, RHA® 3 is a viscoelastic, sterile, non-pyrogenic, clear, colorless, homogenous, and biodegradable gel implant. It is formulated with sodium hyaluronic acid (NaHA) at a concentration of 23 mg/g obtained from bacterial fermentation using the Streptococcus equi bacterial strained, crosslinked with 1,4 butanediol diglycidyl ether (BDDE) and reconstituted in a physiological buffer (pH 7.3). RHA® 3 also contains 0.3% lidocaine hydrochloride to reduce pain on injection. | Device | RHA 3 |
| Restylane-LComparator Product, Restylane-L is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL with 0.3% lidocaine. | Device | Restylane- L |
Primary outcome
Change in TLFS Score (Teoxane Lip Fullness Scale) Between Baseline and Week 12 After Last Treatment of RHA®3 Versus Control Device, as Assessed by the BLE
Time frame: Week 12 after last treatment
A change in the TLFS ≥1 grade compared to pre-treatment will be considered clinically meaningful. The TLFS is a validated 5-point scale for assessing lip augmentation. Possible scores range from 1 (Very Thin) to 5 (Very Full). Change = (Week 12 - Baseline score).
6 secondary outcomes
Change From Baseline in TLFS Score as Assessed by the BLE at Visit 5 (Weeks 24 After Last Treatment), 6 (Weeks 36 After Last Treatment), 7 (Week 52 After Last Treatment) if Applicable, and Re-treatment (4 Weeks After Re-treatment)
Time frame: Weeks 36 and 52 after last treatment, week 4 after re-treatment
Responder Rate Calculated Using TLFS Assessed by the BLE
Time frame: Weeks 12, 36, 52 after last treatment, week 4 after re-treatment
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 12, 36, 52 After Last Treatment and 4 Weeks After Re-treatment.
Time frame: Weeks 12, 36, 52 after last treatment and 4 week after re-treatment.
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Lips" FACE-Q | Aesthetics© Scale Questionnaire at Weeks 12, 36, 52 After Last Treatment and 4 Week After Re-treatment.
Time frame: Change from Baseline at Weeks 12, 36, 52 after last treatment and 4 week after re-treatment.
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Outcome" FACE-Q | Aesthetics© Scale Questionnaire at Weeks 12, 36, 52 After Last Treatment and 4 Week After Re-treatment.
Time frame: Weeks 12, 36, 52 after last treatment and 4 week after re-treatment.
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the BLE.
Time frame: Weeks 12, 36, 52 after last treatment, and 4 weeks after re-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RHA 3 and Restylane-L in people with Lip Augmentation and Lip, run by Teoxane SA at 1 site 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 3 Feb 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 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 15 Dec 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 TLFS Score (Teoxane Lip Fullness Scale) Between Baseline and Week 12 After Last Treatment of RHA®3 Versus Control Device, 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 3 Feb 2025; AzTrials last refreshed its copy on 27 Oct 2026.