A Study to Evaluate Patient Satisfaction With the Overall Face and Neck Appearance After Combined Treatment of OnabotulinumtoxinA, JUVÉDERM® Products, KYBELLA, CoolSculpting Elite and SkinMedica Products

Description

A study to evaluate overall participant satisfaction of face and neck appearance after treatment with onabotulinumtoxinA, JUVÉDERM® products, KYBELLA, CoolSculpting Elite, and select SkinMedica products in a diverse population.

Conditions

Facial Contouring

Study Overview

Study Details

Study overview

A study to evaluate overall participant satisfaction of face and neck appearance after treatment with onabotulinumtoxinA, JUVÉDERM® products, KYBELLA, CoolSculpting Elite, and select SkinMedica products in a diverse population.

US HARMONY in DIVERSITY: A Prospective, Open-label Study to Evaluate Subject Satisfaction With the Overall Face and Neck Appearance After Combined Treatment

A Study to Evaluate Patient Satisfaction With the Overall Face and Neck Appearance After Combined Treatment of OnabotulinumtoxinA, JUVÉDERM® Products, KYBELLA, CoolSculpting Elite and SkinMedica Products

Condition
Facial Contouring
Intervention / Treatment

-

Contacts and Locations

Vista

Pacific Clinical Innovations /ID# 270414, Vista, California, United States, 92083-6030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Must meet at least 1 of the following criteria for BOTOX UFL treatment per investigator's assessment:
  • * Moderate or severe on Allergan Glabellar Line Severity Scale at maximum furrow
  • * Moderate or severe on Forehead Line Severity Scale at maximum brow elevation and Moderate or Severe on Allergan Glabellar Line Severity Scale at maximum furrow
  • * Moderate or severe on Lateral Canthal Line Severity Scale at maximum contraction (identical severity on both sides)
  • * Must meet at least 3 of the following criteria for treatment in the face with at least 2 JUVÉDERM products, per investigator's assessment:
  • * Moderate or severe on Allergan Loss of Jawline Definition Scale
  • * Moderate or severe on Allergan Chin Retrusion Scale
  • * Moderate, significant, or severe on Midface Volume Deficit Scale
  • * Moderate or severe on Nasolabial Fold Severity Scale
  • * Moderate or severe for both eyes on Allergan Infraorbital Hollows Scale
  • * Minimal, mild, or moderate on 5-point Allergan Lip Fullness Scale
  • * Moderate or severe on Allergan Cheek Smoothness Scale
  • * Minimal, moderate, or severe on Allergan Temple Hollowing Scale
  • * History of medical condition that may put the subject at increased medical risk with exposure to OnabotulinumtoxinA, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
  • * History of hypersensitivity or allergy to any botulinum toxin serotype, Streptococcal protein, lidocaine (or any amide-based anesthetics), HA products, any other excipients or constituents of the study drug, device, SkinMedica products and/or other products in the same class.
  • * Marked facial asymmetry (e.g., asymmetry in eyebrow and/or eyelid position, asymmetrical smile or significant asymmetry in the lower face), facial nerve palsy, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart.
  • * Previous plastic surgery, tissue grafting, permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene), or tissue augmentation with silicone, fat, or other permanent dermal fillers of the face and/or neck or plan to undergo any of these procedures at any time during the study.
  • * Prior exposure to botulinum toxin of any serotype to any part of the body within 6 months prior to screening.
  • * Prior treatment with non-permanent soft tissue fillers or fat-reducing injectables in the face or neck within 12 months prior to screening.
  • * Prior treatment with energy-based devices (e.g., intense pulsed light, Clear + Brilliant®, monopolar radiofrequency, microfocused ultrasound, etc.,) or other noninvasive fat reduction procedure and/or skin-tightening laser treatments in the face or neck within 6 months prior to screening.
  • * Current use or planned treatment with weight loss medications during the study (including but not limited to glucagon-like peptide-1 agonists, or glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 agonists).
  • * History of body weight change of \> 10% over the 6 months prior to screening, or anticipated body weight change of \> 10% during the study period.

Ages Eligible for Study

22 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AbbVie,

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

2026-07