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Completed

NCT Number: NCT02559908

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cabinet medical Solferino, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyaluronic Acid Injectable Gel

Device

Hyaluronic Acid Injectable Gel (VYC-25L) injection into the chin and/or jaw areas (up to 4.0 mLs).

Primary outcomes

  1. Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle

    Time frame: Baseline, Month 3

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 25, 2015
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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