N/A
Completed N=71
Multicenter Study to Evaluate the Safety and Efficacy of Revanesse® Ultra Retreatment
Nasolabial Fold Correction
Source: ClinicalTrials.gov NCT02984878 ↗
Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: 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 — 0.1; 0.6; 0.0; 0.8 units on WSRS scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
0.1; 0.6; 0.0; 0.8 | — |
| SECONDARY Retreatment Safety Assessed by the Incidence of Adverse Events (AEs), Which Were Defined, Recorded, Reported, and Evaluated, by Number and Severity |
0; 1; 0; 1; 2; 8 | — |
| SECONDARY Patient Global Aesthetic Improvement (pGAI) Score |
1; 1; 8; 8; 13; 16 | — |
Eligibility Criteria
Inclusion Criteria
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).
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT02984878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.