Clinical trial NCT02984878: Multicenter Study to Evaluate the Safety and Efficacy of Revanesse® Ultra Retreatment
Official title: A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra (Retreatment)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Fold Correction
Lead sponsor: Prollenium Medical Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-07
Enrollment: 71
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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:

-

Primary outcomes:
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
timeFrame: Visit 8/Week 52
Secondary outcomes:
measure: Retreatment Safety Assessed by the Incidence of Adverse Events (AEs), Which Were Defined, Recorded, Reported, and Evaluated, by Number and Severity
timeFrame: Visit 6/Week 24, Visit 7/Week 28, Visit 8/Week 52
measure: Patient Global Aesthetic Improvement (pGAI) Score
timeFrame: Visit 8/Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Tennessee Clinical Research Center
name: Michael H Gold, MD
role: PRINCIPAL_INVESTIGATOR
References: