N/A
N=77
Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers
Facial Wrinkles
Bottom Line
View on ClinicalTrials.gov: NCT01151436 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Full Face Global Aesthetic Improvement — 2.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- hyaluronic acid dermal fillers (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Full Face Global Aesthetic Improvement |
1.8 | — |
| PRIMARY Full Face Global Aesthetic Improvement |
1.8 | — |
| PRIMARY Full Face Global Aesthetic Improvement |
1.8 | — |
| SECONDARY NASOLABIAL FOLDS SEVERITY ASSESSMENT |
2 | — |
| SECONDARY NASOLABIAL FOLDS SEVERITY ASSESSMENT |
2 | — |
| SECONDARY NASOLABIAL FOLDS SEVERITY ASSESSMENT |
2 | — |
| SECONDARY NASOLABIAL FOLDS SEVERITY ASSESSMENT |
2 | — |
| SECONDARY PERIORBITAL LINES SEVERITY ASSESSMENT |
2.1 | — |
| SECONDARY PERIORBITAL LINES SEVERITY ASSESSMENT |
2.1 | — |
| SECONDARY PERIORBITAL LINES SEVERITY ASSESSMENT |
2.1 | — |
| SECONDARY PERIORBITAL LINES SEVERITY ASSESSMENT |
2.1 | — |
| SECONDARY MARIONETTE LINES SEVERITY ASSESSMENT |
2 | — |
| SECONDARY MARIONETTE LINES SEVERITY ASSESSMENT |
2 | — |
| SECONDARY MARIONETTE LINES SEVERITY ASSESSMENT |
2 | — |
| SECONDARY MARIONETTE LINES SEVERITY ASSESSMENT |
2 | — |
| SECONDARY UPPER LIP LINES SEVERITY ASSESSMENT |
2.1 | — |
| SECONDARY UPPER LIP LINES SEVERITY ASSESSMENT |
2.1 | — |
| SECONDARY UPPER LIP LINES SEVERITY ASSESSMENT |
2.1 | — |
| SECONDARY UPPER LIP LINES SEVERITY ASSESSMENT |
2.1 | — |
| SECONDARY CHEEK FOLDS SEVERITY ASSESSMENT |
1.8 | — |
| SECONDARY CHEEK FOLDS SEVERITY ASSESSMENT |
1.8 | — |
| SECONDARY CHEEK FOLDS SEVERITY ASSESSMENT |
1.8 | — |
| SECONDARY CHEEK FOLDS SEVERITY ASSESSMENT |
1.8 | — |
| SECONDARY LIP ENHANCEMENT ASSESSMENT |
2 | — |
| SECONDARY LIP ENHANCEMENT ASSESSMENT |
2 | — |
| SECONDARY LIP ENHANCEMENT ASSESSMENT |
2 | — |
| SECONDARY LIP ENHANCEMENT ASSESSMENT |
2 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01151436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.