A Study of Hyaluronic Acid Injectable Gel (VYC-25L) for Restoration and Creation of Facial Volume in the Chin and Jaw

Allergan

Status: Completed

Conditions: Chin Retrusion

Treatments: Device: Hyaluronic Acid Injectable Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02559908

V25L-001

Details and patient eligibility

About

This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable gel for the restoration and creation of facial volume in participants seeking to increase projection of the chin and/or jaw.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Has chin retrusion.

Exclusion criteria

• Has ever received or is planning to receive permanent facial implants during the study.
• Has tattoos, piercings, facial hair or scars that would interfere with visual assessments of the chin or jaw.
• Has dentures or any device covering part of the palate or plans to undergo any dental procedure other than prophylaxis during the study.
• Has undergone semipermanent dermal filler treatment to the chin or jaw within 36 months or is planning treatment during the study.
• Has undergone any surgery of the chin or jaw area within 24 months or a planned surgery during the study.
• Has undergone mesotherapy, cosmetic resurfacing, or botulinum toxin injections within 6 months or a planned treatment during the study.
• Has experienced trauma to the chin and jaw area within 6 months.
• Has been previously diagnosed with streptococcal disease.
• Has a history of anaphylaxis or allergy to lidocaine, hyaluronic acid or streptococcal protein.
• Has porphyria or untreated epilepsy.
• Has active autoimmune disease.
• Has current cutaneous or mucosal inflammatory or infectious processes, abscess, an unhealed wound, or a cancerous or pre-cancerous lesion.
• Is on a concurrent regimen of lidocaine or structurally-related local anesthetics or is on a concurrent regimen of drugs that reduce or inhibit hepatic metabolism.
• Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction.
• Is on an ongoing regimen of anti-coagulation therapy.
• Is on an ongoing regimen of medications (eg, aspirin, ibuprofen) or other substances known to increase coagulation time (eg, herbal supplements with garlic or gingko biloba) within the past 10 days.
• Has begun using any over-the-counter or prescription oral or topical, anti-wrinkle products below the subnasale within 30 days before enrollment or is planning to begin using such products during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Treatment Group_VYC-25L

Experimental group

Description:

VYC-25L injection into the chin and/or jaw areas on Day 1, volume determined by the investigator (up to 4.0 mLs) and repeat treatment if applicable

Treatment:

Device: Hyaluronic Acid Injectable Gel

Control Group_No treatment then VYC-25L

Other group

Description:

No treatment for 3 months followed by VYC-25L injection into the chin and/or jaw areas, volume determined by the investigator (up to 4.0 mLs) and repeat treatment if applicable.

Treatment:

Device: Hyaluronic Acid Injectable Gel