CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Hyaluronic acid dermal filler geldevice
Likely dose
Emervel Volume hyaluronic acid dermal filler gel; 1 injection per indication and 1 touch-up injection if necessaryAI-extracted
Key inclusion· 3
  • Seeking treatment for correction of facial volume loss
  • Volume loss score of at least 2 (visible depression or descent) on whole face assessment
  • At least 2 of the following areas affected by volume loss: chin, temporal areas, jawlines, cheeks, cheekbones, or deep to very deep nasolabial folds (Lemperle severity ≥4 if cheekbones injected)
Key exclusion· 2
  • Subjects with precautions, warnings, or contraindications per the device package insert
  • Prior permanent filler injection in the areas to be treated

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01545557
NCT01545557N/ACompleted

Pan Facial Volume Restoration With a New Hyaluronic Acid Dermal Filler

Galderma R&D·interventional·Posted Mar 6, 2012·Updated Mar 1, 2023

In Brief

A clinical study evaluating Hyaluronic acid dermal filler gel for Volume Loss (Soft Tissue Ptosis or Atrophy ). Completed, enrolled 60 participants across 3 sites.

Detailed 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%.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 6, 2012
Enrollment StartFeb 21, 2012
Primary CompletionMar 3, 2014
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 14.3 years ago

Interventions

Hyaluronic acid dermal filler geldevice

1 Emervel Volume injection per indication and 1 touch-up injection if necessary