NCT01545557

Pan Facial Volume Restoration

Pan Facial Volume Restoration With a New Hyaluronic Acid Dermal Filler

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%.

Detailed 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).

Conditions

• Volume Loss (Soft Tissue Ptosis or Atrophy )

Interventions

Type	Name	Description
DEVICE	Hyaluronic acid dermal filler gel	1 Emervel Volume injection per indication and 1 touch-up injection if necessary

Timeline

• Start date: 2012-02-21
• Primary completion: 2014-03-03
• Completion: 2014-03-03
• First posted: 2012-03-06
• Last updated: 2023-03-01
• Results posted: 2023-03-01

Locations

3 sites across 1 country: Brazil