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Non-comparative Evaluation of Facial Expressions Following Lower Face Correction Using Emervel Classic and Emervel Deep

NCT02672644 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-07-29

No results posted yet for this study

Summary

Study is designed to characterize subject and treating investigator reported outcomes in the early post-treatment period, following bilateral correction of nasolabial folds using Emervel Classic and Emervel Deep.

1. to evaluate subject-reported return to social engagement, after the initial treatment (Baseline/Day 1 visit).
2. to evaluate change in Global Aesthetic Improvement Scale (GAIS) at day 30- subject/investigator reported
3. to evaluate subject satisfaction with treatment outcome at baseline, day 14 and day 30.
4. to evaluate change in Wrinkle Severity Rating Scale (WSRS) from baseline to post-treatment follow-up time points at day 14 and Day 30 - investigator reported
5. to evaluate all adverse events during the course of the study

Conditions

  • Nasolabial Folds
  • Wrinkles

Interventions

DEVICE

Emervel Classic

Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Classic (moderate NLFs; WSRS = 3/3)

DEVICE

Emervel Deep

Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Deep (severe NLFs; WSRS = 4/4).

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Principal Investigators

  • Author Swift, MD · Arthur Swift Research Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Canada

Study Locations

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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 NCT02672644 on ClinicalTrials.gov