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Completed

NCT Number: NCT02833077

A Safety and Effectiveness Study of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation

This is a safety and effectiveness study of JUVÉDERM VOLUMA XC injectable gel for chin augmentation to correct volume deficit in chin retrusion.

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Key information

Conditions

Chin Retrusion

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc., San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chin retrusion
  • In good general health

Exclusion criteria

  • Permanent facial implants on the face and/or neck
  • Received fat injections below the nose
  • Tattoos, piercings, beard, mustache, and/or scars on the face below the nose
  • Received semi-permanent dermal fillers in the chin or jaw line in the last 3 years
  • Undergone dermal filler injections or had any surgery in the chin or jaw area in the last 2 years
  • Received dermal filler injections in the lips or in the mouth area in the last 12 months
  • Undergone mesotherapy or cosmetic treatment (e.g., laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck in the last 6 months
  • Received botulinum toxin treatment below the nose in the last 6 months

Treatment and study plan

JUVÉDERM VOLUMA® XC

Device

JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator. The maximum total volume administered was up to 4 mL.

Primary outcomes

  1. Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score

    Time frame: Baseline (up to 30 days prior to randomization) to Month 6

    The evaluating investigator assessed the participant's chin retrusion based on 2-dimensional (2D) renderings of 3-dimensional (3D) images using the validated 5-point photonumeric ACRS where: 0= None (no chin retrusion) to 4=Extreme (extreme chin retrusion).

Secondary outcomes

  1. Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire

    Time frame: Baseline (up to 30 days prior to randomization) to Month 6

    The participant answered 10 question on the chin module of the FACE-Q about their satisfaction with their chin using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied and 4=Very Satisfied. The total score was transformed to a score of 0 (worse) to 100 (best). A positive change from Baseline indicates improvement.

  2. Percentage of Participants Improved or Much Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS) for the Chin Area As Assessed by the Evaluating Investigator

    Time frame: Baseline (up to 30 days prior to randomization) to Month 6

    The evaluating investigator assessed the participant's chin area using the GAIS where: 2=Much Improved, 1=Improved, 0=No change, -1=Worse and -2=Much Worse.

  3. Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants

    Time frame: Baseline (up to 30 days prior to randomization) to Month 6

    The participants who received JUVÉDERM VOLUMA® XC, assessed their chin area using the GAIS where: 2=Much Improved, 1=Improved, 0=No change, -1=Worse and -2=Much Worse.

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 JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2016
Registry last updated
Jul 23, 2020

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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