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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revanesse Ultra | Experimental | Revanesse Ultra open label retreatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revanesse Ultra | Device | Nasolabial Fold correction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 8/Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Subjects from the SYM2014-02 initial study who were:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Michael H Gold, MD | Tennessee Clinical Research Center | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Revanesse Ultra Retreatment | Revanesse Ultra: Nasolabial Fold correction - - Subjects could have open-label retreatment as needed with Revanesse Ultra at 6 months if their WSRS scores had returned to baseline |
| FG001 | Revanesse Ultra Optimal Correction | The Optimal Correction group scores had not returned to baseline, subjects were eligible to be injected for either one or both NLFs as needed to achieve optimal correction (optimal correction group). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Revanesse Ultra open label retreatment / Nasolabial Fold correction - 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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Revanesse Ultra Retreatment | Revanesse Ultra open label retreatment / Nasolabial Fold correction - optional open-label retreatment with Revanesse Ultra for subjects who had returned to baseline Wrinkle Severity Rating Scale (WSRS) score The subjects completing the initial phase of the SYM2014-02 study (NCT02987205) who had returned to baseline Wrinkle Severity Rating Scale (WSRS) score, were offered the option for retreatment with Revanesse Ultra Safety data was collected to assess treatment emergent adverse events associated with repeat injections. Seventy-one subjects received retreatment - 30 returned to baseline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects that completed the SYM 2014-02 Main Study were eligible for the SYM 2014-02 Retreatment Study. | Posted | Mean | Standard Deviation | units on WSRS scale | Visit 8/Week 52 | Nasolabial Folds | Nasolabial Folds |
Adverse Event data was collected at Retreatment for 6 months (Visit 8/Week 52 from the Main Study)
Treatment safety was evaluated by frequency and percent of subjects and investigators reporting treatment-emergent adverse events (TEAEs) tabulated by treatment group, location, frequency, severity and duration after each treatment (initial treatment, touch up) and throughout the study. TEAEs were assessed by a subject diary after each injection, touch up and follow up visit, and were reported by the Evaluating Investigator at each of the follow-up visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Retreatment Group | Revanesse Ultra open label retreatment for Nasolabial Fold correction. Optional Open-label Retreatment at Visit 6/Week 24 of the SYM 2014-02 Main Study, a subject could be retreated when WSRS scores had returned to baseline for either or both NLFs. The retreatment group and the optimal correction group were separated for data analysis. These subjects continued to day 196 (Visit 7 / week 28), received a phone contact at day 280 (week 40), and completed at day 364 (Visit 8 / week 52). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INJECTION SITE ERYTHEMA | General disorders | MedDRA (15.1) | Non-systematic Assessment | Counts reflect numbers of subjects reporting one or more injection site TEAEs that map to the MedDRA (version 15.1). At each level of summarization (SOC or preferred term) subjects reporting more than one injection site TEAE are only counted once. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ario Khoshbin, President | Prollenium Medical Technologies, Inc. | 866-353-3015 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 12, 2017 | Dec 12, 2017 | Prot_000.pdf |
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| 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 | Visit 8/Week 52 |
| BG001 | Revanesse Ultra Optimal Correction | Revanesse Ultra open label retreatment / Nasolabial Fold correction - optional open-label retreatment with Revanesse Ultra for subjects as needed for optimal correction if WSRS scores had not returned to baseline. The subjects completing the initial phase of the SYM2014-02 study (NCT02987205) were treated as needed for optimal correction if WSRS scores had not returned to baseline, and were offered the option for retreatment with Revanesse Ultra Safety data was collected to assess treatment emergent adverse events associated with repeat injections. Seventy-one subjects received retreatment - 41 were included in the optimal correction group |
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Customized | participants in each age group | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Fitzpatrick Skin Type (FST) Classification | FST Type I skin always burns, never tans (pale white; blond or red hair; blue, gray eyes; freckles), FST Type II skin usually burns, tans minimally (white; blond, brown or red hair; blue, green, or hazel eyes), FST Type III skin sometimes has a mild burn, tans uniformly (cream white; yellowish; any hair color or brown eyes), FST Type IV skin burns minimally, always tans well (light brown; olive; dark brown to black hair), FST Type V skin very rarely burns, tans very easily (brown), FST Type VI skin never burns, always tans (deeply pigmented dark brown to darkest brown, black in complexion) | Count of Participants | Participants |
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| Secondary | 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 | Counts reflect numbers of subjects reporting one or more injection site TEAE that map to the MedDRA (version 15.1) system organ class/preferred term. At each level of summarization (system organ class or preferred term), subjects reporting more than one injection site TEAE are counted only once. | Posted | Count of Participants | Participants | Visit 6/Week 24, Visit 7/Week 28, Visit 8/Week 52 |
|
|
|
| Secondary | 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 | Subjects were evaluated on the Patient Global Aesthetic Improvement (pGAI) | Posted | Count of Participants | Participants | Visit 8/Week 52 |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 16 |
| 30 |
| EG001 | Optimal Correction Group | Optional Open label Retreatment at Week 24 / SYM2014-02 Retreatment: At SYM 2014-02 Main Study Visit 6/Week 24, a subject could be retreated with Revanesse Ultra. Subjects were eligible for optimal correction when WSRS scores had not returned to baseline. Optimal Correction subjects were injected in either one or both NLFs as needed to achieve optimal correction. These subjects continued to day 196 (Visit 7 / week 28), received a phone contact at day 280 (week 40), and completed at day 364 (Visit 8 / week 52). | 0 | 41 | 0 | 41 | 29 | 41 |
|
| INJECTION SITE HAEMATOMA | General disorders | MedDRA (15.1) | Non-systematic Assessment | bruising |
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| INJECTION SITE PAIN | General disorders | MedDRA (15.1) | Non-systematic Assessment | pain at the injection site |
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| INJECTION SITE SWELLING | General disorders | MedDRA (15.1) | Non-systematic Assessment | Swelling at the injection site |
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There are restrictions within the site contracts, sites cannot publish any results and also have confidentiality agreements in place separately that restrict any publications by sites regarding results, findings, etc.
| Injection site erythema |
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| Injection site haematoma |
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| Injection site mass |
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| Injection site pain |
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| Injection site pruritis |
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| Injection site swelling |
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| Contusion |
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| Excoriation |
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| Visit 8 - week 52 pGAI = 3 Improved |
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| Visit 8 - week 52 pGAI = 4 much improved |
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| Visit 8 - week 52 pGAI = 5 Very much improved |
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