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OpenTrials
Completed

NCT Number: NCT06783621

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

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.

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Key information

Conditions

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Marcus Facial Plastic Surgery /ID# 270408, Redondo Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Applies to All Participants:

  • 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

Applies only to participants who will be treated for submental fullness:

  • Moderate or severe on the Clinician-reported Submental Fat Rating Scale (for KYBELLA treatment) or Moderate, severe, or extreme (For CoolSculpting Elite treatment) per investigator's assessment.

Exclusion criteria

  • 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.

Treatment and study plan

OnabotulinumtoxinA

Drug

Intramuscular Injections

JUVÉDERM

Device

Injections

Other names: VOLUX XC, VOLUMA XC, VOLLURE XC, VOLBELLA XC, SKINVIVE, ULTRA PLUS XC, ULTRA XC

CoolSculpting Elite System

Device

CoolSculpting Elite Applicator

SkinMedica Products

Other

Skincare Product

Kybella

Drug

Injections

Primary outcomes

  1. Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Satisfaction with Facial Appearance Scale at the Final Visit

    Time frame: Up to approximately 284 days

    The FACE-Q Satisfaction with Facial Appearance is a validated questionnaire that asks participants to report their level of satisfaction with the appearance of their face.

Secondary outcomes

  1. Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Psychological Function Scale at the Final Visit

    Time frame: Up to approximately 284 days

    The FACE-Q Psychological Function is a validated questionnaire that asks participants to report their level of satisfaction with psychological function.

  2. Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale at the Final Visit

    Time frame: Up to approximately 284 days

    The FACE-Q Social Function Scale is a validated questionnaire that asks participants to report their level of satisfaction with social function.

  3. Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale at the Final Visit

    Time frame: Up to approximately 284 days

    The SKIN-Q Scale is a validated questionnaire that asks participants to report their level of satisfaction with skin quality.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: US Harmony

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
May 22, 2026

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.