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

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ClinicalTrials.gov Identifier: NCT02984878
Recruitment Status : Completed
First Posted : December 7, 2016
Results First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Prollenium Medical Technologies Inc.

Tracking Information
First Submitted Date  ICMJE December 5, 2016
First Posted Date  ICMJE December 7, 2016
Results First Submitted Date  ICMJE August 28, 2017
Results First Posted Date  ICMJE December 20, 2017
Last Update Posted Date December 20, 2017
Study Start Date  ICMJE November 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2017)
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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2017)
  • Retreatment Safety Assessed by the Incidence of Adverse Events (AEs), Which Were Defined, Recorded, Reported, and Evaluated, by Number and Severity [ Time Frame: Visit 6/Week 24, Visit 7/Week 28, Visit 8/Week 52 ]
    Assess safety concerns with retreatment of Revanesse Ultra for men or women at least 22 years of age with NLFs with a moderate or severe WSRS score at baseline who had previously received 1 or 2 treatments with Restylane or Revanesse Ultra, Adverse Events (AEs), which were defined, recorded, reported, and evaluated
  • Patient Global Aesthetic Improvement (pGAI) Score [ Time Frame: Visit 8/Week 52 ]
    Subjects were evaluated on the Patient Global Aesthetic Improvement (pGAI) Patient Global Aesthetic Improvement (pGAI) Score: 1 = Worse, 2 = No change, 3 = Improved, 4 = Much improved, 5 = Very much improved
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicenter Study to Evaluate the Safety and Efficacy of Revanesse® Ultra Retreatment
Official Title  ICMJE A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra (Retreatment)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasolabial Fold Correction
Intervention  ICMJE Device: Revanesse Ultra
Nasolabial Fold correction
Study Arms  ICMJE Experimental: Revanesse Ultra
Revanesse Ultra open label retreatment
Intervention: Device: Revanesse Ultra
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2017)
71
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02984878
Other Study ID Numbers  ICMJE SYM2014-02 Retreatment
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Prollenium Medical Technologies Inc.
Study Sponsor  ICMJE Prollenium Medical Technologies Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael H Gold, MD Tennessee Clinical Research Center
PRS Account Prollenium Medical Technologies Inc.
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP