Clinical trial 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
Official title: US HARMONY in DIVERSITY: A Prospective, Open-label Study to Evaluate Subject Satisfaction With the Overall Face and Neck Appearance After Combined Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Facial Contouring
Keywords: Facial Contouring
OnabotulinumtoxinA
JUVEDERM Products
KYBELLA
CoolSculpting Elite
SkinMedica
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 with submental fat:

- 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.
* 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.

Primary outcomes:
measure: Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Satisfaction with Facial Appearance Scale at the Final Visit
timeFrame: Up to approximately 284 days
Secondary outcomes:
measure: Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Psychological Function Scale at the Final Visit
timeFrame: Up to approximately 284 days
measure: Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale at the Final Visit
timeFrame: Up to approximately 284 days
measure: Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale at the Final Visit
timeFrame: Up to approximately 284 days
Other outcomes:
Locations:
city: Redondo Beach
country: United States
facility: Marcus Facial Plastic Surgery /ID# 270408
state: California
city: Vista
country: United States
facility: Pacific Clinical Innovations /ID# 270414
state: California
city: Washington
country: United States
facility: Center for Dermatology and Dermatologic Surgery /ID# 270390
state: District of Columbia
city: Coral Gables
country: United States
facility: Skin Research Institute LLC /ID# 270410
state: Florida
city: New Orleans
country: United States
facility: DelRicht Research - New Orleans 308 /ID# 270425
state: Louisiana
city: Birmingham
country: United States
facility: Boyd /Id# 270509
state: Michigan
city: New York
country: United States
facility: Luxurgery /ID# 270430
state: New York
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates /ID# 270429
state: Texas
city: Spring
country: United States
facility: Integrated Aesthetics /ID# 270399
state: Texas
city: Arlington
country: United States
facility: SkinDC /ID# 270411
state: Virginia
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: