NCT01976663

A Safety and Effectiveness Study of JUVÉDERM VOLIFT® XC Versus Control for Moderate to Severe Nasolabial Folds

A Prospective, Multicenter, Within-subject Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLIFT® XC Versus Control for the Correction of Moderate to Severe Nasolabial Folds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multicenter, within-subject controlled study of the safety and effectiveness of JUVÉDERM VOLIFT® XC versus Control for the correction of moderate to severe nasolabial folds (NLFs).

Conditions

• Moderate to Severe Nasolabial Folds

Interventions

Type	Name	Description
DEVICE	JUVEDERM VOLIFT® XC	Up to 4 mLs JUVEDERM VOLIFT® XC injected intradermally in one NLF (total; including initial and touch-up treatments) and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. For asymmetric correction, only the more severe NLF is eligible for asymmetric correction.
DEVICE	Control	Up to 4 mLs Control injected intradermally in opposite NLF (total; including initial and touch-up treatments). Up to 4 mLs JUVEDERM VOLIFT XC is allowed for asymmetry correction and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. Only the more severe NLF is eligible for asymmetric correction.

Timeline

• Start date: 2013-10-29
• Primary completion: 2015-03-17
• Completion: 2015-10-26
• First posted: 2013-11-06
• Last updated: 2019-05-10
• Results posted: 2017-05-22

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study