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

Facial Wrinkles Clinical Trial

— FRESH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151436
• Other study ID #: RD.03.CIP.29089
• Secondary ID: 2009-018163-28
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: February 2011

Study information

• Verified date: May 2012
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: February 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Facial Wrinkles
• Facies

Intervention

Device:
• hyaluronic acid dermal fillers
1 injection per indication and 1 touch-up injection if necessary

Locations

Country	Name	City	State
France	Galderma investigational site	Arras
France	Galderma investigational site	Nice
France	Galderma investigational site	Paris
Germany	Galderma investigational site	Berlin
Germany	Galderma investigational site	Darmstadt

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Full Face Global Aesthetic Improvement	Global aesthetic improvement scale score from baseline: -1: worse 0: no change; improved; much improved; very much improved	3 weeks after last injection
Primary	Full Face Global Aesthetic Improvement	Global aesthetic improvement scale score from baseline: -1: worse 0: no change; improved; much improved; very much improved	3 months after last injection
Primary	Full Face Global Aesthetic Improvement	Global aesthetic improvement scale score from baseline: -1: worse 0: no change; improved; much improved; very much improved	6 months after last injection
Secondary	NASOLABIAL FOLDS SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	baseline
Secondary	NASOLABIAL FOLDS SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	3 weeks after last injection
Secondary	NASOLABIAL FOLDS SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	3 months after last injection
Secondary	NASOLABIAL FOLDS SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	6 months after last injection
Secondary	PERIORBITAL LINES SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	baseline
Secondary	PERIORBITAL LINES SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	3 weeks after last injection
Secondary	PERIORBITAL LINES SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	3 MONTHS AFTER LAST INJECTION
Secondary	PERIORBITAL LINES SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	6 MONTHS AFTER LAST INJECTION
Secondary	MARIONETTE LINES SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	BASELINE
Secondary	MARIONETTE LINES SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	3 WEEKS AFTER LAST INJECTION
Secondary	MARIONETTE LINES SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	3 MONTHS AFTER LAST INJECTION
Secondary	MARIONETTE LINES SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	6 MONTHS AFTER LAST INJECTION
Secondary	UPPER LIP LINES SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	BASELINE
Secondary	UPPER LIP LINES SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	3 WEEKS AFTER LAST INJECTION
Secondary	UPPER LIP LINES SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	3 MONTHS AFTER LAST INJECTION
Secondary	UPPER LIP LINES SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	6 MONTHS AFTER LAST INJECTION
Secondary	CHEEK FOLDS SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	BASELINE
Secondary	CHEEK FOLDS SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	3 WEEKS AFTER LAST INJECTION
Secondary	CHEEK FOLDS SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	3 MONTHS AFTER LAST INJECTION
Secondary	CHEEK FOLDS SEVERITY ASSESSMENT	Severity scored on Lemperle Rating Scale: 0: no wrinkles; just perceptible wrinkle; shallow wrinkle; moderately deep wrinkle; deep wrinkle, well-defined edges; very deep wrinkle redundant fold	6 MONTHS AFTER LAST INJECTION
Secondary	LIP ENHANCEMENT ASSESSMENT	Lip fullness grading scale score: 0: very thin lip; thin lip; moderately thick lip; thick lip; full lip	baseline
Secondary	LIP ENHANCEMENT ASSESSMENT	Lip fullness grading scale score: 0: very thin lip; thin lip; moderately thick lip; thick lip; full lip	3 WEEKS AFTER LAST INJECTION
Secondary	LIP ENHANCEMENT ASSESSMENT	Lip fullness grading scale score: 0: very thin lip; thin lip; moderately thick lip; thick lip; full lip	3 MONTHS AFTER LAST INJECTION
Secondary	LIP ENHANCEMENT ASSESSMENT	Lip fullness grading scale score: 0: very thin lip; thin lip; moderately thick lip; thick lip; full lip	6 MONTHS AFTER LAST INJECTION