NCT01305187

Non-inferiority of Belotero® Basic Versus Juvéderm® Ultra 3

Monocentric, Randomized, Subject and Rater Blinded Clinical Investigation to Prove the Non-inferiority of Belotero® Basic Versus Juvéderm® Ultra 3 Containing Lidocaine - After Single Injection for Correction of Nasolabial Folds (NLF)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will investigate the non-inferiority of Belotero® Basic versus Juvéderm® Ultra 3 in the treatment of nasolabial folds

Conditions

• Physiological Stress
• Disorder of Aging
• Skin Diseases
• Wrinkles
• Nasolabial Folds

Interventions

Type	Name	Description
DEVICE	Hyaluronic Acid Filler	The dosage is individualized depending on the depth of the NLF. The goal is to achieve optimal correction of both NLF with single implantations of Belotero® Basic and Juvéderm® Ultra 3 respectively. Each subject will be injected with Belotero® Basic and Lidocaine containing Juvéderm® Ultra 3 according to a split-face design. The allocation of fillers to the side of the face will be randomized. The randomization method is block-wise with a ratio 1:1 to the groups Belotero® Basic left and Juvéderm® Ultra 3 right, Belotero® Basic right and Juvéderm® Ultra 3 left.

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2011-02-28
• Last updated: 2011-06-20

Locations

1 site across 1 country: Germany