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

NCT02984878 | Completed Results DMC FDA Device

• 1 other identifier: SYM2014-02 Retreatment
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nasolabial Fold Correction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Retreatment Safety Assessed by the Incidence of Adverse Events (AEs), Which Were Defined, Recorded, Reported, and Evaluated, by Number and Severity

  Visit 6/Week 24, Visit 7/Week 28, Visit 8/Week 52

• Patient Global Aesthetic Improvement (pGAI) Score

  Visit 8/Week 52

Study Arms (1)

Revanesse Ultra

EXPERIMENTAL

Revanesse Ultra open label retreatment

Device: Revanesse Ultra

Interventions

Revanesse Ultra DEVICE

Nasolabial Fold correction

Revanesse Ultra

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Prollenium Medical Technologies Inc.: lead

Results Point of Contact

• Title: Ario Khoshbin, President
• Organization: Prollenium Medical Technologies, Inc.

866-353-3015

Study Officials

• Michael H Gold, MD

  Tennessee Clinical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 7, 2016
• Study Start: November 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 20, 2017
• Results First Posted: December 20, 2017

Record last verified: 2017-10