Overview

This trial is active, not recruiting.

Condition chin retrusion
Treatment hyaluronic acid injectable gel
Sponsor Allergan
Start date February 2015
End date February 2016
Trial size 120 participants
Trial identifier NCT02559908, V25L-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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
hyaluronic acid injectable gel
Hyaluronic Acid Injectable Gel (VYC-25L) injection into the chin and/or jaw areas (up to 4.0 mLs).
(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.
hyaluronic acid injectable gel
Hyaluronic Acid Injectable Gel (VYC-25L) injection into the chin and/or jaw areas (up to 4.0 mLs).

Primary Outcomes

Measure
Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
time frame: Baseline, Month 3

Secondary Outcomes

Measure
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)
time frame: Month 3
Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS
time frame: Month 3

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Allergan.