NCT03425253

Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour

A Prospective, Open-label Study to Evaluate Sequential Treatment With BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study has been designed to evaluate the safety and effectiveness of sequential treatment with BELKYRA® (for the treatment of convexity and fullness associated with submental fat) and VOLUMA™ (to restore volume along the mandibular border) to enhance the overall contour of the jawline.

Detailed description

Participants may be treated with up to 6 treatments with Belkyra, followed by treatment with Voluma. Participants will have opportunity to participation in a skin biopsy sub-study.

Conditions

• Contour

Interventions

Type	Name	Description
DRUG	BELKYRA®	BELKYRA® was injected into preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart).
DEVICE	Juvéderm® VOLUMA™ with Lidocaine	Juvéderm® VOLUMA™ with Lidocaine VOLUMA™ was injected along the mandibular border.

Timeline

• Start date: 2018-02-02
• Primary completion: 2019-12-05
• Completion: 2019-12-05
• First posted: 2018-02-07
• Last updated: 2020-12-31
• Results posted: 2020-12-31

Locations

3 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study
• FDA-regulated device study