Nasolabial Fold CorrectionRetreatmentNCT02984878
Multicenter Study to Evaluate the Safety and Efficacy of Revanesse® Ultra Retreatment
A study testing Revanesse Ultra in people with Nasolabial Fold Correction, run by Prollenium Medical Technologies Inc..
Trial summary
To compare improvement with retreatment for all subjects undergoing correction of nasolabial folds (NLFs) in the initial SYM2014-02 study, who were retreated with Revanesse Ultra at Visit 6/Week 24 and to determine the safety of repeat injections of Revanesse Ultra. The retreatment phase was optional. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Sep 2016
- 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 from the SYM2014-02 initial study who were:
- Men or women at least 22 years of age with two fully visible bilateral nasolabial folds each with a WSRS score of 3 or 4 (moderate or severe) that may have been corrected with an injectable dermal filler.
- Subjects were eligible for retreatment when WSRS scores had returned to baseline for either or both NLFs (retreatment group).
- If scores had not returned to baseline, subjects were also eligible to be injected for either one or both NLFs as needed to achieve optimal correction (optimal correction group).
Who cannot join
- -
About this study
Official title: A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra (Retreatment)
To compare improvement with retreatment for all subjects undergoing correction of nasolabial folds (NLFs) in the initial SYM2014-02 study, who were retreated with Revanesse Ultra at Visit 6/Week 24 and to determine the safety of repeat injections of Revanesse Ultra. The retreatment phase was optional.
Read the detailed description
The subjects completing the initial phase of the SYM2014-02 study (NCT02987205) who had returned to baseline Wrinkle Severity Rating Scale (WSRS) score or as needed for optimal correction if WSRS scores had not returned to baseline, were offered the option for retreatment with Revanesse Ultra
Visit 6/Week 24 (± 7 days) optional open-label retreatment with Revanesse Ultra for subjects who had returned to baseline Wrinkle Severity Rating Scale (WSRS) score or as needed for optimal correction if WSRS scores had not returned to baseline; End of Study for subjects not being retreated
Visit 7/Week 28 (± 7 days) follow-up for retreated subjects
Visit 8/Week 52 (± 7 days) End of Study for retreated subjects
A telephone contact was performed at Week 40 (± 7 days) for retreated subjects to assess adverse events (AEs) and concomitant medications.
This report presents the results for all subjects who received optional open-label retreatment with Revanesse Ultra at Visit 6/Week 24.
This study was performed in compliance with Good Clinical Practice (GCP), including the archiving of essential documents.
Number of Subjects (Planned and Analyzed): Seventy-one subjects received retreatment.
- Conditions
- Nasolabial Fold Correction
- Being tested
- Revanesse Ultra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revanesse UltraDevice
Nasolabial Fold correction
| Study group | Role | What they receive |
|---|---|---|
| Revanesse Ultra | Experimental | Revanesse Ultra open label retreatment Receives: Device: Revanesse Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Wrinkle Severity Rating Scale (WSRS) With Subjects From Both the Retreatment and the Optimal Correction Groups - WSRS Scores at Visit 8/Week 52
Change in the Wrinkle Severity Rating Scale (WSRS) With Subjects From Both the Retreatment and the Optimal Correction Groups Achieving Similar WSRS Scores at Visit 8/Week 52 - WSRS Score categories: 1. Absent - No visible fold; continuous skin line. 2. Mild - Shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance. 3. Moderate - Moderately deep folds; clear facial feature visible at normal appearance but not when stretched; excellent correction is expected from injectable implant. 4. Severe - Very long and deep folds; prominent facial feature; less than 2 mm visible when stretched; significant improvement is expected from injectable implant. 5. Extreme - Extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone. An increase in the WSRS score indicates a worsening of severity.
Measured: Visit 8/Week 52
Secondary outcomes (2)
Retreatment Safety Assessed by the Incidence of Adverse Events (AEs), Which Were Defined, Recorded, Reported, and Evaluated, by Number and Severity
Assess safety concerns with retreatment of Revanesse Ultra for men or women at least 22 years of age with NLFs with a moderate or severe WSRS score at baseline who had previously received 1 or 2 treatments with Restylane or Revanesse Ultra, Adverse Events (AEs), which were defined, recorded, reported, and evaluated
Measured: Visit 6/Week 24, Visit 7/Week 28, Visit 8/Week 52
Patient Global Aesthetic Improvement (pGAI) Score
Subjects were evaluated on the Patient Global Aesthetic Improvement (pGAI) Patient Global Aesthetic Improvement (pGAI) Score: 1 = Worse, 2 = No change, 3 = Improved, 4 = Much improved, 5 = Very much improved
Measured: Visit 8/Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startNov 2015
- Primary completionSep 2016
- Study completionSep 2016
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
- Masking
- None (open label)
- Enrolment
- 71 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 Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984878
- Sponsor's protocol ID
- SYM2014-02 Retreatment
- Acronym
- Retreatment
- Status last verified
- Oct 2017
- First submitted
- 5 Dec 2016
- Last updated
- 20 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. 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 (Retreatment)
- ClinicalTrials.gov ID
- NCT02984878
- Acronym / sponsor ID
- Retreatment / SYM2014-02 Retreatment
- Conditions
- Nasolabial Fold Correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Prollenium Medical Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Posted 20 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare improvement with retreatment for all subjects undergoing correction of nasolabial folds (NLFs) in the initial SYM2014-02 study, who were retreated with Revanesse Ultra at Visit 6/Week 24 and to determine the safety of repeat injections of Revanesse Ultra. The retreatment phase was optional.
Detailed description
The subjects completing the initial phase of the SYM2014-02 study (NCT02987205) who had returned to baseline Wrinkle Severity Rating Scale (WSRS) score or as needed for optimal correction if WSRS scores had not returned to baseline, were offered the option for retreatment with Revanesse Ultra
Visit 6/Week 24 (± 7 days) optional open-label retreatment with Revanesse Ultra for subjects who had returned to baseline Wrinkle Severity Rating Scale (WSRS) score or as needed for optimal correction if WSRS scores had not returned to baseline; End of Study for subjects not being retreated
Visit 7/Week 28 (± 7 days) follow-up for retreated subjects
Visit 8/Week 52 (± 7 days) End of Study for retreated subjects
A telephone contact was performed at Week 40 (± 7 days) for retreated subjects to assess adverse events (AEs) and concomitant medications.
This report presents the results for all subjects who received optional open-label retreatment with Revanesse Ultra at Visit 6/Week 24.
This study was performed in compliance with Good Clinical Practice (GCP), including the archiving of essential documents.
Number of Subjects (Planned and Analyzed): Seventy-one subjects received retreatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revanesse Ultra | Experimental | Device: Revanesse UltraRevanesse Ultra open label retreatment |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women at least 22 years of age with two fully visible bilateral nasolabial folds each with a WSRS score of 3 or 4 (moderate or severe) that may have been corrected with an injectable dermal filler.
- Subjects were eligible for retreatment when WSRS scores had returned to baseline for either or both NLFs (retreatment group).
- If scores had not returned to baseline, subjects were also eligible to be injected for either one or both NLFs as needed to achieve optimal correction (optimal correction group).
Key exclusion criteria (1 listed)
- -
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 UltraNasolabial Fold correction | Device | Revanesse Ultra |
Primary outcome
Change in the Wrinkle Severity Rating Scale (WSRS) With Subjects From Both the Retreatment and the Optimal Correction Groups - WSRS Scores at Visit 8/Week 52
Time frame: Visit 8/Week 52
Change in the Wrinkle Severity Rating Scale (WSRS) With Subjects From Both the Retreatment and the Optimal Correction Groups Achieving Similar WSRS Scores at Visit 8/Week 52 - WSRS Score categories: 1. Absent - No visible fold; continuous skin line. 2. Mild - Shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance. 3. Moderate - Moderately deep folds; clear facial feature visible at normal appearance but not when stretched; excellent correction is expected from injectable implant. 4. Severe - Very long and deep folds; prominent facial feature; less than 2 mm visible when stretched; significant improvement is expected from injectable implant. 5. Extreme - Extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone. An increase in the WSRS score indicates a worsening of severity.
2 secondary outcomes
Retreatment Safety Assessed by the Incidence of Adverse Events (AEs), Which Were Defined, Recorded, Reported, and Evaluated, by Number and Severity
Time frame: Visit 6/Week 24, Visit 7/Week 28, Visit 8/Week 52
Patient Global Aesthetic Improvement (pGAI) Score
Time frame: Visit 8/Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Nasolabial Fold Correction
Recruiting
A Study to Confirm Safety and Effectiveness of RADIESSE® Injectable Implant for the Correction of Moderate to Severe Nasolabial Folds
Nasolabial Folds
Not yet recruiting
Dermal Evaluation of Facetem™ S in Nasolabial Folds Esthetics Improvement: DEFINE Study
Nasolabial Folds
RecruitingPhase 3
Study to Assess Adverse Events and How Effective NOA LIFT is Compared to JUVÉDERM VOLIFT With Lidocaine for the Correction of Nasolabial Folds in Adults
Nasolabial Folds
Recruiting
THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER
Lips Enhancement Nasolabial Fold Correction Midface Volume Deficit
Active, not recruitingObservational study
Filler Post Market Survey (FIPS)
Wrinkle Reduction
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 Center
Questions about this trial
What is this clinical trial studying?
A study testing Revanesse Ultra in people with Nasolabial Fold Correction, run by Prollenium Medical Technologies Inc..
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 4 inclusion and 1 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 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 20 Dec 2017). 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 the Wrinkle Severity Rating Scale (WSRS) With Subjects From Both the Retreatment and the Optimal Correction Groups - WSRS Scores at Visit 8/Week 52 (time frame: Visit 8/Week 52). 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 20 Dec 2017.