CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 58 enrolled
Drug / intervention
BELKYRA® +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03425253
NCT03425253Phase 4Completed
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A Prospective, Open-label Study to Evaluate Sequential Treatment With BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour

Allergan·interventional·Posted Feb 7, 2018·Updated Dec 31, 2020

In Brief

A Phase 4 clinical trial evaluating BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine for Contour. Completed, enrolled 58 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContour
CountriesAustralia
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedFeb 7, 2018
Enrollment StartFeb 2, 2018
Primary CompletionDec 5, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.4 years ago

Interventions

BELKYRA®drug

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).

Juvéderm® VOLUMA™ with Lidocainedevice

Juvéderm® VOLUMA™ with Lidocaine VOLUMA™ was injected along the mandibular border.