NCT02984878

Multicenter Study to Evaluate the Safety and Efficacy of Revanesse® Ultra Retreatment

A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra (Retreatment)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Prollenium Medical Technologies Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Revanesse Ultra	Nasolabial Fold correction

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2016-12-07
• Last updated: 2017-12-20
• Results posted: 2017-12-20

Regulatory

• FDA-regulated device study