Clinical trial NCT01151436: Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers
Official title: Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers - Investigator and Subject Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Wrinkles
Keywords: Facial wrinkle correction
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-06-28
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Full Face Global Aesthetic Improvement
timeFrame: 3 weeks after last injection
measure: Full Face Global Aesthetic Improvement
timeFrame: 3 months after last injection
measure: Full Face Global Aesthetic Improvement
timeFrame: 6 months after last injection
Secondary outcomes:
measure: NASOLABIAL FOLDS SEVERITY ASSESSMENT
timeFrame: baseline
measure: NASOLABIAL FOLDS SEVERITY ASSESSMENT
timeFrame: 3 weeks after last injection
measure: NASOLABIAL FOLDS SEVERITY ASSESSMENT
timeFrame: 3 months after last injection
measure: NASOLABIAL FOLDS SEVERITY ASSESSMENT
timeFrame: 6 months after last injection
measure: PERIORBITAL LINES SEVERITY ASSESSMENT
timeFrame: baseline
measure: PERIORBITAL LINES SEVERITY ASSESSMENT
timeFrame: 3 weeks after last injection
measure: PERIORBITAL LINES SEVERITY ASSESSMENT
timeFrame: 3 MONTHS AFTER LAST INJECTION
measure: PERIORBITAL LINES SEVERITY ASSESSMENT
timeFrame: 6 MONTHS AFTER LAST INJECTION
measure: MARIONETTE LINES SEVERITY ASSESSMENT
timeFrame: BASELINE
measure: MARIONETTE LINES SEVERITY ASSESSMENT
timeFrame: 3 WEEKS AFTER LAST INJECTION
measure: MARIONETTE LINES SEVERITY ASSESSMENT
timeFrame: 3 MONTHS AFTER LAST INJECTION
measure: MARIONETTE LINES SEVERITY ASSESSMENT
timeFrame: 6 MONTHS AFTER LAST INJECTION
measure: UPPER LIP LINES SEVERITY ASSESSMENT
timeFrame: BASELINE
measure: UPPER LIP LINES SEVERITY ASSESSMENT
timeFrame: 3 WEEKS AFTER LAST INJECTION
measure: UPPER LIP LINES SEVERITY ASSESSMENT
timeFrame: 3 MONTHS AFTER LAST INJECTION
measure: UPPER LIP LINES SEVERITY ASSESSMENT
timeFrame: 6 MONTHS AFTER LAST INJECTION
measure: CHEEK FOLDS SEVERITY ASSESSMENT
timeFrame: BASELINE
measure: CHEEK FOLDS SEVERITY ASSESSMENT
timeFrame: 3 WEEKS AFTER LAST INJECTION
measure: CHEEK FOLDS SEVERITY ASSESSMENT
timeFrame: 3 MONTHS AFTER LAST INJECTION
measure: CHEEK FOLDS SEVERITY ASSESSMENT
timeFrame: 6 MONTHS AFTER LAST INJECTION
measure: LIP ENHANCEMENT ASSESSMENT
timeFrame: baseline
measure: LIP ENHANCEMENT ASSESSMENT
timeFrame: 3 WEEKS AFTER LAST INJECTION
measure: LIP ENHANCEMENT ASSESSMENT
timeFrame: 3 MONTHS AFTER LAST INJECTION
measure: LIP ENHANCEMENT ASSESSMENT
timeFrame: 6 MONTHS AFTER LAST INJECTION
Other outcomes:
Locations:
city: Arras
country: France
facility: Galderma investigational site
city: Nice
country: France
facility: Galderma investigational site
city: Paris
country: France
facility: Galderma investigational site
city: Berlin
country: Germany
facility: Galderma investigational site
city: Darmstadt
country: Germany
facility: Galderma investigational site
Study officials:
affiliation: Investigational site Nice France
name: Philippe KESTEMONT
role: PRINCIPAL_INVESTIGATOR
References: