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

Prollenium Medical Technologies

Status

Completed

Conditions

Nasolabial Fold Correction

Treatments

Device: Revanesse Ultra

Study type

Interventional

Funder types

Industry

Identifiers

NCT02984878

SYM2014-02 Retreatment

Details and patient eligibility

About

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.

Full 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.

Enrollment

71 patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

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