Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers (FRESH)

February 16, 2021 updated by: Galderma R&D

Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers - Investigator and Subject Satisfaction

The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction linked to the global management of facial rejuvenation with a new range of hyaluronic acid dermal fillers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The range of fillers tested in this study includes 5 different hyaluronic acid dermal fillers: Emervel Touch, Emervel Classic, Emervel Deep, Emervel Volume and Emervel Lips.

The study will last 6 month.

Injections will be performed at baseline. If necessary, the investigator will perform touch-up injections at the following visit (3 weeks later).

Investigator and subject satisfaction will be collected through questionnaires.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Arras, France
        • Galderma Investigational Site
      • Nice, France
        • Galderma Investigational Site
      • Paris, France
        • Galderma Investigational Site
  • Germany
      • Berlin, Germany
        • Galderma Investigational Site
      • Darmstadt, Germany
        • Galderma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Seeking tissue augmentation treatment on the face,
  • Presenting a score of 3 (Moderately deep wrinkle)or 4 (Deep wrinkle) on the Lemperle Rating Scale (LRS) of both nasolabial folds.

Exclusion Criteria:

  • At risk in term of precautions, warnings and contra-indication referred in the package insert of the study devices,
  • Who underwent previous injection of permanent filler in the injected area.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: hyaluronic acid
Device: hyaluronic acid dermal fillers
1 injection per indication and 1 touch-up injection if necessary
Other Names:
  • Facial wrinkles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full Face Global Aesthetic Improvement
Time Frame: 3 weeks after last injection

Global aesthetic improvement scale score from baseline:

-1: worse 0: no change

  1. improved
  2. much improved
  3. very much improved
3 weeks after last injection
Full Face Global Aesthetic Improvement
Time Frame: 3 months after last injection

Global aesthetic improvement scale score from baseline:

-1: worse 0: no change

  1. improved
  2. much improved
  3. very much improved
3 months after last injection
Full Face Global Aesthetic Improvement
Time Frame: 6 months after last injection

Global aesthetic improvement scale score from baseline:

-1: worse 0: no change

  1. improved
  2. much improved
  3. very much improved
6 months after last injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NASOLABIAL FOLDS SEVERITY ASSESSMENT
Time Frame: baseline

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
baseline
NASOLABIAL FOLDS SEVERITY ASSESSMENT
Time Frame: 3 weeks after last injection

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
3 weeks after last injection
NASOLABIAL FOLDS SEVERITY ASSESSMENT
Time Frame: 3 months after last injection

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
3 months after last injection
NASOLABIAL FOLDS SEVERITY ASSESSMENT
Time Frame: 6 months after last injection

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
6 months after last injection
PERIORBITAL LINES SEVERITY ASSESSMENT
Time Frame: baseline

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
baseline
PERIORBITAL LINES SEVERITY ASSESSMENT
Time Frame: 3 weeks after last injection

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
3 weeks after last injection
PERIORBITAL LINES SEVERITY ASSESSMENT
Time Frame: 3 MONTHS AFTER LAST INJECTION

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
3 MONTHS AFTER LAST INJECTION
PERIORBITAL LINES SEVERITY ASSESSMENT
Time Frame: 6 MONTHS AFTER LAST INJECTION

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
6 MONTHS AFTER LAST INJECTION
MARIONETTE LINES SEVERITY ASSESSMENT
Time Frame: BASELINE

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
BASELINE
MARIONETTE LINES SEVERITY ASSESSMENT
Time Frame: 3 WEEKS AFTER LAST INJECTION

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
3 WEEKS AFTER LAST INJECTION
MARIONETTE LINES SEVERITY ASSESSMENT
Time Frame: 3 MONTHS AFTER LAST INJECTION

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
3 MONTHS AFTER LAST INJECTION
MARIONETTE LINES SEVERITY ASSESSMENT
Time Frame: 6 MONTHS AFTER LAST INJECTION

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
6 MONTHS AFTER LAST INJECTION
UPPER LIP LINES SEVERITY ASSESSMENT
Time Frame: BASELINE

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
BASELINE
UPPER LIP LINES SEVERITY ASSESSMENT
Time Frame: 3 WEEKS AFTER LAST INJECTION

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
3 WEEKS AFTER LAST INJECTION
UPPER LIP LINES SEVERITY ASSESSMENT
Time Frame: 3 MONTHS AFTER LAST INJECTION

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
3 MONTHS AFTER LAST INJECTION
UPPER LIP LINES SEVERITY ASSESSMENT
Time Frame: 6 MONTHS AFTER LAST INJECTION

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
6 MONTHS AFTER LAST INJECTION
CHEEK FOLDS SEVERITY ASSESSMENT
Time Frame: BASELINE

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
BASELINE
CHEEK FOLDS SEVERITY ASSESSMENT
Time Frame: 3 WEEKS AFTER LAST INJECTION

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
3 WEEKS AFTER LAST INJECTION
CHEEK FOLDS SEVERITY ASSESSMENT
Time Frame: 3 MONTHS AFTER LAST INJECTION

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
3 MONTHS AFTER LAST INJECTION
CHEEK FOLDS SEVERITY ASSESSMENT
Time Frame: 6 MONTHS AFTER LAST INJECTION

Severity scored on Lemperle Rating Scale:

0: no wrinkles

  1. just perceptible wrinkle
  2. shallow wrinkle
  3. moderately deep wrinkle
  4. deep wrinkle, well-defined edges
  5. very deep wrinkle redundant fold
6 MONTHS AFTER LAST INJECTION
LIP ENHANCEMENT ASSESSMENT
Time Frame: baseline

Lip fullness grading scale score:

0: very thin lip

  1. thin lip
  2. moderately thick lip
  3. thick lip
  4. full lip
baseline
LIP ENHANCEMENT ASSESSMENT
Time Frame: 3 WEEKS AFTER LAST INJECTION

Lip fullness grading scale score:

0: very thin lip

  1. thin lip
  2. moderately thick lip
  3. thick lip
  4. full lip
3 WEEKS AFTER LAST INJECTION
LIP ENHANCEMENT ASSESSMENT
Time Frame: 3 MONTHS AFTER LAST INJECTION

Lip fullness grading scale score:

0: very thin lip

  1. thin lip
  2. moderately thick lip
  3. thick lip
  4. full lip
3 MONTHS AFTER LAST INJECTION
LIP ENHANCEMENT ASSESSMENT
Time Frame: 6 MONTHS AFTER LAST INJECTION

Lip fullness grading scale score:

0: very thin lip

  1. thin lip
  2. moderately thick lip
  3. thick lip
  4. full lip
6 MONTHS AFTER LAST INJECTION

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Principal Investigator: Philippe KESTEMONT, Investigational site Nice France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

June 24, 2010

First Submitted That Met QC Criteria

June 25, 2010

First Posted (ESTIMATE)

June 28, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.CIP.29089
  • 2009-018163-28 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Facial Wrinkles

Clinical Trials on hyaluronic acid dermal fillers

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe