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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nasolabial Fold Correction Device: Revanesse Ultra Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra (Retreatment)
Study Start Date : November 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Revanesse Ultra
Revanesse Ultra open label retreatment
 Device: Revanesse Ultra
Nasolabial Fold correction


Outcome Measures
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Primary Outcome Measures :
  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 [ 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.


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984878


Sponsors and Collaborators
Prollenium Medical Technologies Inc.
Investigators
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Principal Investigator: Michael H Gold, MD Tennessee Clinical Research Center
  Study Documents (Full-Text)

Documents provided by Prollenium Medical Technologies Inc.:
Study Protocol  [PDF] December 12, 2017

More Information
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Responsible Party: Prollenium Medical Technologies Inc.
ClinicalTrials.gov Identifier: NCT02984878    
Other Study ID Numbers: SYM2014-02 Retreatment
First Posted: December 7, 2016    Key Record Dates
Results First Posted: December 20, 2017
Last Update Posted: December 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Device Product: Yes