N/A
N=60
Pan Facial Volume Restoration
Volume Loss (Soft Tissue Ptosis or Atrophy )
Bottom Line
View on ClinicalTrials.gov: NCT01545557 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Mean Change From Baseline in Volume Loss Assessment — -0.8 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hyaluronic acid dermal filler gel (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Volume Loss Assessment |
-0.8 | — |
| SECONDARY Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection |
32.2; 67.8 | — |
| SECONDARY Percentage of Investigators Satisfied With the Use of Study Hyaluronic Acid Dermal Filler |
100 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
9 | — |
| SECONDARY Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection |
25; 70 | — |
Summary
The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction further to pan-facial volume restoration with a new cross-linked hyaluronic acid dermal filler containing lidocaine 0.3%.
Eligibility Criteria
Inclusion Criteria
- Subjects seeking treatment for correction of volume loss.
- Subjects presenting a score of at least 2 (visible depression or descent) for whole face on the volume loss scale and at least 2 indications affected by volume loss among the following: chin temporal areas, jawlines, cheeks, cheekbones, deep to very deep nasolabial folds (severity score 4 at least on Lemperle rating scale) if cheekbones are injected.
Exclusion Criteria
- Subjects at risk in term of precautions, warnings and contraindication referred in the package insert of the study device,
- Subjects who underwent previous injection of permanent filler in the injected area.
Data sourced from ClinicalTrials.gov (NCT01545557). 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.