Chin Retrusion
Conditions
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.
Interventions
DEVICEHyaluronic Acid Injectable Gel
Hyaluronic Acid Injectable Gel (VYC-25L) injection into the chin and/or jaw areas (up to 4.0 mLs).
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle | Baseline, Month 3 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France, Germany, Netherlands
Outcome results
None listed