A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions (BEAM)

Allergan

Status and phase: Completed; Phase 4

Conditions: Cheek Line Depressions

Treatments: Device: Juvéderm® VOLIFT®™ with Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02980783

GMA-EAME-FAS-0397

Details and patient eligibility

About

This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic radial cheek line skin depressions.

Enrollment: 53 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of dynamic radial cheek lines
• Agrees not to make any changes to skin care routines, or to have any facial procedures or treatments during the study

Exclusion criteria

• Previous facial surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures during the study
• Undergone temporary facial dermal filler injections with any substance in the face in the 12 months prior to study entry
• Received botulinum toxin therapy of any serotype in any facial area within the previous 6 months agrees not to receive it during the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Juvéderm® VOLIFT®™ with Lidocaine

Experimental group

Description:

Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.

Treatment:

Device: Juvéderm® VOLIFT®™ with Lidocaine