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

Not Applicable

Completed

• Conditions: Facial Wrinkles
• Interventions: Device: hyaluronic acid dermal fillers

• Registration Number: NCT01151436
• Lead Sponsor: Galderma R&D

Brief Summary

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.

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 Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-06-24
• Study First Submitted QC: 2010-06-25
• Study First Posted: 2010-06-28
• Primary Completion: 2010-11
• Study Completion: 2011-02
• Results First Submitted: 2012-04-10
• Results First Submitted QC: 2012-04-10
• Status Verified: 2012-05
• Results First Posted: 2012-05-07
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hyaluronic acid	hyaluronic acid dermal fillers	-

Primary Outcome Measures

Name	Time	Method
Full Face Global Aesthetic Improvement	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

Secondary Outcome Measures

Name	Time	Method
PERIORBITAL LINES SEVERITY ASSESSMENT	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
CHEEK FOLDS SEVERITY ASSESSMENT	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
NASOLABIAL FOLDS SEVERITY ASSESSMENT	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
UPPER LIP LINES SEVERITY ASSESSMENT	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
MARIONETTE LINES SEVERITY ASSESSMENT	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
LIP ENHANCEMENT ASSESSMENT	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

Trial Locations

Locations (1)

Galderma investigational site; 🇩🇪 Darmstadt, Germany