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 (US Harmony)

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 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.

Study Overview

• Status: Completed
• Conditions: Facial Contouring
• Intervention / Treatment: Drug: OnabotulinumtoxinA; Device: JUVÉDERM; Device: CoolSculpting Elite System; Other: SkinMedica Products; Drug: KYBELLA

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Redondo Beach, California, United States, 90277
      • Marcus Facial Plastic Surgery /ID# 270408
    • Vista, California, United States, 92083-6030
      • Pacific Clinical Innovations /ID# 270414
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037-1495
      • Center for Dermatology and Dermatologic Surgery /ID# 270390
  • Florida
    • Coral Gables, Florida, United States, 33146-1837
      • Skin Research Institute LLC /ID# 270410
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Research - Prytania Street - New Orleans 308 /ID# 270425
  • Michigan
    • Birmingham, Michigan, United States, 48009-6301
      • Boyd /Id# 270509
  • New York
    • New York, New York, United States, 10021
      • Luxurgery /ID# 270430
  • Texas
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates /ID# 270429
    • Spring, Texas, United States, 77388
      • Integrated Aesthetics /ID# 270399
  • Virginia
    • Arlington, Virginia, United States, 22209
      • SkinDC /ID# 270411

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Open-Label Combination Treatments; All participants in the study will receive treatment with onabotulinumtoxinA and JUVÉDERM (specific products and indications will be at the discretion of the investigator and per participant eligibility criteria).	Drug: OnabotulinumtoxinA; Intramuscular Injections; Device: JUVÉDERM; Injections; Other Names: VOLUX XC; VOLUMA XC; VOLLURE XC; VOLBELLA XC; SKINVIVE; ULTRA PLUS XC; ULTRA XC; Device: CoolSculpting Elite System; CoolSculpting Elite Applicator; Other: SkinMedica Products; Skincare Product; Drug: KYBELLA; Injections
Experimental: Cohort 2: Open-Label Combination Treatments; All participants in the study will receive treatment with onabotulinumtoxinA and JUVÉDERM (specific products and indications will be at the discretion of the investigator and per participant eligibility criteria).	Drug: OnabotulinumtoxinA; Intramuscular Injections; Device: JUVÉDERM; Injections; Other Names: VOLUX XC; VOLUMA XC; VOLLURE XC; VOLBELLA XC; SKINVIVE; ULTRA PLUS XC; ULTRA XC; Other: SkinMedica Products; Skincare Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Satisfaction with Facial Appearance Scale at the Final Visit	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.	Up to approximately 284 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Psychological Function Scale at the Final Visit	The FACE-Q Psychological Function is a validated questionnaire that asks participants to report their level of satisfaction with psychological function.	Up to approximately 284 days
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale at the Final Visit	The FACE-Q Social Function Scale is a validated questionnaire that asks participants to report their level of satisfaction with social function.	Up to approximately 284 days
Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale at the Final Visit	The SKIN-Q Scale is a validated questionnaire that asks participants to report their level of satisfaction with skin quality.	Up to approximately 284 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Actual): March 20, 2026
• Study Completion (Actual): March 20, 2026

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: OnabotulinumtoxinA; Facial Contouring; JUVEDERM Products; KYBELLA; CoolSculpting Elite; SkinMedica
• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Polycyclic Compounds; Hydrolases; Enzymes; Enzymes and Coenzymes; Steroids; Fused-Ring Compounds; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Cholic Acids; Bile Acids and Salts; Cholanes; Botulinum Toxins, Type A; Deoxycholic Acid
• Other Study ID Numbers: M24-704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No