NCT02559908CompletedNot Applicable
A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of VYC-25L Hyaluronic Acid Injectable Gel for Restoration and Creation of Facial Volume in the Chin and Jaw
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 120
- Locations
- 10
- Primary Endpoint
- Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Treatment Group_VYC-25L
Experimental
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
Intervention: Hyaluronic Acid Injectable Gel (Device)
Control Group_No treatment then VYC-25L
Other
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.
Intervention: Hyaluronic Acid Injectable Gel (Device)
Outcomes
Primary Outcomes
Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
Time Frame: Baseline, Month 3
Secondary Outcomes
- Percentage of Responders based on the Investigator's Assessment of Improvement in the Chin and Jaw Area using the 5-point Global Aesthetic Improvement Scale (GAIS)(Month 3)
- Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS(Month 3)
Investigators
Study Sites (10)
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