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Emervel for the Correction of Lower Face Wrinkles & Folds

NCT02718040 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-08-01

Study results available
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Summary

This study is designed to

1. evaluate the naturalness of facial expressions in motion (2D video images), by treating investigator assessment
2. evaluate naturalness of facial expressions (photographs), by treating investigator assessment
3. evaluate perceived attractiveness and age of subject (2D videos), by treating investigator assessment
4. evaluate aesthetic improvement, by subject and treating investigator assessments
5. evaluate subject satisfaction
6. evaluate nasolabial fold (NLF) severity, by treating investigator assessment
7. evaluate marionette lines (MLs) severity, by treating investigator assessment
8. evaluate dynamic facial strain in animation using 3D digital photogrammetric analysis
9. evaluate all adverse events reported during the study.

Conditions

  • Nasolabial Folds
  • Marionette Lines
  • Wrinkles

Interventions

DEVICE

Emervel Classic and/or Deep Treatment Group

Severity of Wrinkle Severity treated by product type: Emervel Classic: Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 2/2, 2/3 or 3/3; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 2/2, 2/3 or 3/3 Emervel Deep Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 3/3, 3/4 or 4/4; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 3/3, 3/4 or 4/4 Both products may be used in the same subject, but only in different anatomic locations. The same study product should be used within the same wrinkle or fold type (e.g., left and right NLFs treated with the same product)

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Principal Investigators

  • Jay Mashburn · Galderma Laboratories

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-07-31
Completion
2016-08-31

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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 NCT02718040 on ClinicalTrials.gov