MedTrace Logo

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

NCT02984878 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2017-12-20

Study results available
· View outcomes & findings →

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

Interventions

DEVICE

Revanesse Ultra

Nasolabial Fold correction

Sponsors & Collaborators

  • Prollenium Medical Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Michael H Gold, MD · Tennessee Clinical Research Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-09-30
Completion
2016-09-30
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02984878 on ClinicalTrials.gov