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
1 other identifier
interventional
130
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2025
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2025
CompletedStudy Start
First participant enrolled
January 16, 2025
CompletedFirst Posted
Study publicly available on registry
January 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2026
CompletedMarch 27, 2026
March 1, 2026
1.1 years
January 15, 2025
March 25, 2026
Conditions
Keywords
Outcome Measures
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
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 Outcomes (3)
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Psychological Function Scale at the Final Visit
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
Up to approximately 284 days
Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale at the Final Visit
Up to approximately 284 days
Study Arms (2)
Cohort 1: Open-Label Combination Treatments
EXPERIMENTALAll 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).
Cohort 2: Open-Label Combination Treatments
EXPERIMENTALAll 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).
Interventions
Injections
CoolSculpting Elite Applicator
Skincare Product
Intramuscular Injections
Eligibility Criteria
You may qualify if:
- 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:
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (10)
Marcus Facial Plastic Surgery /ID# 270408
Redondo Beach, California, 90277, United States
Pacific Clinical Innovations /ID# 270414
Vista, California, 92083-6030, United States
Center for Dermatology and Dermatologic Surgery /ID# 270390
Washington D.C., District of Columbia, 20037-1495, United States
Skin Research Institute LLC /ID# 270410
Coral Gables, Florida, 33146-1837, United States
DelRicht Research - New Orleans 308 /ID# 270425
New Orleans, Louisiana, 70115, United States
Boyd /Id# 270509
Birmingham, Michigan, 48009-6301, United States
Luxurgery /ID# 270430
New York, New York, 10021, United States
Bellaire Dermatology Associates /ID# 270429
Bellaire, Texas, 77401, United States
Integrated Aesthetics /ID# 270399
Spring, Texas, 77388, United States
SkinDC /ID# 270411
Arlington, Virginia, 22209, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2025
First Posted
January 20, 2025
Study Start
January 16, 2025
Primary Completion
February 26, 2026
Study Completion
February 26, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.