A Safety and Effectiveness Study of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation

Allergan

Status: Completed

Conditions: Chin Retrusion

Treatments: Device: JUVÉDERM VOLUMA® XC

Study type: Interventional

Funder types: Industry

Identifiers

NCT02833077

Voluma-006

Details and patient eligibility

About

This is a safety and effectiveness study of JUVÉDERM VOLUMA XC injectable gel for chin augmentation to correct volume deficit in chin retrusion.

Enrollment: 221 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chin retrusion
• In good general health

Exclusion criteria

• Permanent facial implants on the face and/or neck
• Received fat injections below the nose
• Tattoos, piercings, beard, mustache, and/or scars on the face below the nose
• Received semi-permanent dermal fillers in the chin or jaw line in the last 3 years
• Undergone dermal filler injections or had any surgery in the chin or jaw area in the last 2 years
• Received dermal filler injections in the lips or in the mouth area in the last 12 months
• Undergone mesotherapy or cosmetic treatment (e.g., laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck in the last 6 months
• Received botulinum toxin treatment below the nose in the last 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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221 participants in 2 patient groups

JUVÉDERM VOLUMA® XC

Experimental group

Description:

JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 milliliters (mL) for both treatments combined.

Treatment:

Device: JUVÉDERM VOLUMA® XC

No Treatment then JUVÉDERM VOLUMA® XC

Other group

Description:

No treatment for 6 months followed by optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.

Treatment:

Device: JUVÉDERM VOLUMA® XC