NCT01205061

Emervel® Deep Lidocaine vs. Juvederm® Ultra Plus in Treatment of Moderate to Severe Facial Wrinkles and Folds

A Pivotal USA Randomized, Evaluator-blinded, Active-controlled, Multi-center, Split-face Comparison Study of Emervel® Deep Lidocaine Versus Juvederm® Ultra Plus in the Treatment of Moderate to Severe Facial Wrinkles and Folds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to compare the effectiveness and safety of Emervel Deep Lidocaine versus Juvederm Ultra Plus in the treatment of moderate to severe facial wrinkles and folds.

Detailed description

This was a randomized, evaluator-blinded, active-controlled, multi-center, split-face comparison study of Emervel Deep Lidocaine versus Juvederm Ultra Plus in the treatment of moderate to severe facial wrinkles and folds. Two physicians, an Unblinded Injecting Investigator and a Blinded Evaluating Investigator, were required at each study center. The Unblinded Injecting Investigator was different from the Blinded Evaluating Investigator.

Conditions

• Skin Wrinkling

Interventions

Type	Name	Description
DEVICE	Emervel Deep Lidocaine	20 mg/mL + 0.3% lidocaine
DEVICE	Juvederm Ultra Plus	24mg/mL

Timeline

• Start date: 2010-09-27
• Primary completion: 2011-06-20
• Completion: 2012-01-12
• First posted: 2010-09-20
• Last updated: 2023-10-23
• Results posted: 2023-10-23

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study