Nasolabial Fold CorrectionNCT02991040
Study to Evaluate Safety and Efficacy of Revanesse® Ultra + vs Revanesse® Ultra for Correction of NLF
A study testing Revanesse Ultra+ (with lidocaine) and Revanesse Ultra in people with Nasolabial Fold Correction, run by Prollenium Medical Technologies Inc. at 1 site in United States.
Trial summary
A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra + (with Lidocaine) versus Revanesse® Ultra for the Correction of Nasolabial Folds to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine, hereafter referred to as Revanesse Ultra… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Fold Correction
- What is being tested?
- Revanesse Ultra+ (with lidocaine) and Revanesse Ultra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Aug 2017
- 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
- Subjects must meet all of the following criteria to be eligible for the study:
- Men or women 22 years of age or older seeking augmentation therapy for correction of bilateral nasolabial folds.
- Two fully visible bilateral nasolabial folds each with a Wrinkle Severity Rating Scale Score (WSRS) of 3 or 4 that may be corrected with an injectable dermal filler. The NLFs should be symmetrical, i.e., WSRS scores at NLFs on both sides should be the same (both Moderate [3] or both Severe [4]).
- If female and of childbearing potential, a negative urine pregnancy test and agree to use adequate contraception. Female subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 2 years) must have a negative urine pregnancy test and must be willing to use a medically accepted method of contraception during the study. The following are considered acceptable methods of birth control for the purpose of this study: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double barrier methods (e.g., condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active. Subjects entering the study who are on hormonal contraceptives must have been on the method for at least 90 days prior to the study and continue the method for the duration of the study. Subjects who had used hormonal contraception and stopped must have stopped no less than 90 days prior to Visit 1/Day 1.
- Ability to understand and comply with the requirements of the study.
- Willingness and ability to provide written informed consent. 6. Agree to refrain from seeking other treatment for this condition during the study.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- Wrinkle Severity Rating Scale Score of ≤ 2 on the right or left nasolabial fold.
- Women who are pregnant or lactating.
- Received prior dermabrasion, facelift, or Botox below the orbital rim, or had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months (180 days) prior to study entry.
- Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry.
- Has ever received semi-permanent fillers anywhere in the face or neck, or is planning to be implanted with these products during the study.
Show all 22Show fewer
- Has a permanent implant placed in the NLF area.
- Evidence of scar-related disease or delayed healing activity within the past 1 year.
- Scars at the intended treatment sites.
- History of keloid formation or hypertrophic scars.
- Any infection or unhealed wound on the face.
- Allergic history including anaphylaxis, multiple severe allergies, atopy, or allergies to natural rubber latex, lidocaine or any amide-based anesthetic, hyaluronic acid products, or Streptococcal proteins or have plans to undergo desensitization therapy during the term of the study.
- Aspirin or nonsteroidal anti-inflammatory drugs within 1 week (7 days) prior to treatment.
- Concomitant anticoagulant therapy, antiplatelet therapy, or history of bleeding disorders, coagulation defects or connective tissue disorders.
- Over-the-counter (OTC) wrinkle products or prescription wrinkle treatments within 4 weeks (28 days) prior to treatment and throughout the study.
- Immunocompromised or immunosuppressed.
- Clinically significant organic disease including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, preclude participation in the trial.
- Received any investigational product within 30 days of signing the Informed Consent Form.
- Facial tattoo that may interfere with diagnosis.
- Systemic (oral/injectable) corticosteroids or immunosuppressive medications within 30 days prior to treatment and topical steroids on the face within 14 days prior to treatment start and throughout the study.
- Acne and/or other inflammatory diseases of the skin.
- Acute or chronic skin disease, inflammation or related conditions, cancerous or precancerous lesions on or near the injection sites.-
Trial locations and contacts
1 site in 1 country.
United States1 site
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
About this study
Official title: A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra + (With Lidocaine) Versus Revanesse® Ultra for the Correction of Nasolabial Folds (NLF)
A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra + (with Lidocaine) versus Revanesse® Ultra for the Correction of Nasolabial Folds to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine, hereafter referred to as Revanesse Ultra +) to Revanesse Ultra for subjects undergoing correction of nasolabial folds (NLFs)
Read the detailed description
This is a randomized, multicenter, double-blind, split-face study in subjects seeking nasolabial fold correction. Subjects will be treated with Revanesse Ultra + in the NLF on one side of the face and Revanesse Ultra in the NLF on the other side of the face. The side of the face for each study product will be randomly assigned. The investigator and the subject will be blinded to the treatment; injections of the study product will be performed by an unblinded injecting investigator.
At each visit, investigator and subject evaluations of the treated areas will be performed and recorded
- Conditions
- Nasolabial Fold Correction
- Being tested
- Revanesse Ultra+ (with lidocaine), Revanesse Ultra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revanesse Ultra+ (with lidocaine)Device
Also called Revanesse Versa+
Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)
Revanesse UltraDevice
Also called Revanesse Versa
Comparator without lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Revanesse Ultra+ | Experimental | Revanesse Ultra+ (with lidocaine) vs Revanesse Ultra without lidocaine Receives: Device: Revanesse Ultra+ (with lidocaine); Device: Revanesse Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at Injection as Measured by Subject on a 100 mm Visual Analog Scale (VAS) Scale at Time 0 Minutes Post Injection
Visual Analog Scale for Pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher scores mean a worse outcome
Measured: at injection Time 0
Secondary outcomes (4)
Pain Measured by Subject on 100 mm VAS Scale at 15, 30, 45, and 60 Minutes Post Injection and at 2 Weeks Post Injection
Visual Analog Scale for pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher score means a worse outcome.
Measured: 15, 30, 45, and 60 minutes post injection and at 2 weeks post injection
Wrinkle Severity Rating Score (WSRS)
The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome.
Measured: Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)
Patient Global Aesthetic Improvement
Patient Global Aesthetic Improvement Score is a 5-point scale used to assess the subject's satisfaction with the visual appearance of their NLF correction after treatment. 1 = Worse (worst outcome), 2 = No Change, 3 = Improved, 4 = Much Improved, 5 = Very Much improved (best outcome). The higher scores mean a better outcome.
Measured: Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)
Investigator Global Aesthetic Improvement
Investigator Global Aesthetic Improvement Score is a 5-point scale with 1 = Worse (worst outcome); 2 = No Change; 3 = Improved; 4 = Much Improved, 5 = Very much improved (best outcome). The higher scores mean a better outcome.
Measured: Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017
- Study completionAug 2017
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 Nasolabial Fold CorrectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects were treated with Revanesse Ultra in the NLF on one side of the face and Revanesse Ultra+ in the NLF on the other side of the face. The side of the face for each study product was randomly assigned.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prollenium Medical Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael H. Gold, MD, Principal investigator, Tennessee Clinical Research, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991040
- Sponsor's protocol ID
- SYM2016-02
- Status last verified
- Mar 2019
- First submitted
- 6 Dec 2016
- Last updated
- 11 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra + (With Lidocaine) Versus Revanesse® Ultra for the Correction of Nasolabial Folds (NLF)
- ClinicalTrials.gov ID
- NCT02991040
- Acronym / sponsor ID
- SYM2016-02
- Conditions
- Nasolabial Fold Correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Prollenium Medical Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Posted 11 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra + (with Lidocaine) versus Revanesse® Ultra for the Correction of Nasolabial Folds to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine, hereafter referred to as Revanesse Ultra +) to Revanesse Ultra for subjects undergoing correction of nasolabial folds (NLFs)
Detailed description
This is a randomized, multicenter, double-blind, split-face study in subjects seeking nasolabial fold correction. Subjects will be treated with Revanesse Ultra + in the NLF on one side of the face and Revanesse Ultra in the NLF on the other side of the face. The side of the face for each study product will be randomly assigned. The investigator and the subject will be blinded to the treatment; injections of the study product will be performed by an unblinded injecting investigator.
At each visit, investigator and subject evaluations of the treated areas will be performed and recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
- Model description
- Subjects were treated with Revanesse Ultra in the NLF on one side of the face and Revanesse Ultra+ in the NLF on the other side of the face. The side of the face for each study product was randomly assigned.
| Arm | Type | Receives |
|---|---|---|
| Revanesse Ultra+ | Experimental | Device: Revanesse Ultra+ (with lidocaine), Device: Revanesse UltraRevanesse Ultra+ (with lidocaine) vs Revanesse Ultra without lidocaine |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must meet all of the following criteria to be eligible for the study:
Key exclusion criteria (22 listed)
- Wrinkle Severity Rating Scale Score of ≤ 2 on the right or left nasolabial fold.
- Women who are pregnant or lactating.
- Received prior dermabrasion, facelift, or Botox below the orbital rim, or had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months (180 days) prior to study entry.
- Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry.
- Has ever received semi-permanent fillers anywhere in the face or neck, or is planning to be implanted with these products during the study.
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 |
|---|---|---|
| Revanesse Ultra+ (with lidocaine)Also: Revanesse Versa+Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator) | Device | Revanesse Ultra+ |
| Revanesse UltraAlso: Revanesse VersaComparator without lidocaine | Device | Revanesse Ultra+ |
Primary outcome
Pain at Injection as Measured by Subject on a 100 mm Visual Analog Scale (VAS) Scale at Time 0 Minutes Post Injection
Time frame: at injection Time 0
Visual Analog Scale for Pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher scores mean a worse outcome
4 secondary outcomes
Pain Measured by Subject on 100 mm VAS Scale at 15, 30, 45, and 60 Minutes Post Injection and at 2 Weeks Post Injection
Time frame: 15, 30, 45, and 60 minutes post injection and at 2 weeks post injection
Wrinkle Severity Rating Score (WSRS)
Time frame: Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)
Patient Global Aesthetic Improvement
Time frame: Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)
Investigator Global Aesthetic Improvement
Time frame: Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Michael H. Gold, MD principal investigator
Tennessee Clinical Research, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revanesse Ultra+ (with lidocaine) and Revanesse Ultra in people with Nasolabial Fold Correction, run by Prollenium Medical Technologies Inc. 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 6 inclusion and 22 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 11 Apr 2019. 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 11 Apr 2019). 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?
Pain at Injection as Measured by Subject on a 100 mm Visual Analog Scale (VAS) Scale at Time 0 Minutes Post Injection (time frame: at injection Time 0). 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 11 Apr 2019.