Pan Facial Volume Restoration (EVE)
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Treatments
Details and patient eligibility
About
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%.
Full description
Clinical hypothesis: The global approach of the subject pan-facial dermal volume depletion and face soft-tissue contour defects correction using specific dermal filler for all indications to be injected will satisfy both subjects and investigators.
This device will be used for full face correction of volume loss: chin, temporal areas, jawline, cheek, cheekbones, deep to very deep nasolabial folds (only if cheekbones are injected concomitantly).
Study duration will be up to 19 months. Injections will be performed at baseline. If necessary, investigator will perform touch-up injections at the following visit (3 weeks after baseline injection).
Enrollment
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Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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