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
NCT ID: NCT06783621
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
130 participants
INTERVENTIONAL
2025-01-16
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
OnabotulinumtoxinA
Intramuscular Injections
JUVÉDERM
Injections
CoolSculpting Elite System
CoolSculpting Elite Applicator
SkinMedica Products
Skincare Product
KYBELLA
Injections
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).
OnabotulinumtoxinA
Intramuscular Injections
JUVÉDERM
Injections
SkinMedica Products
Skincare Product
Interventions
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OnabotulinumtoxinA
Intramuscular Injections
JUVÉDERM
Injections
CoolSculpting Elite System
CoolSculpting Elite Applicator
SkinMedica Products
Skincare Product
KYBELLA
Injections
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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 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.
22 Years
65 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Marcus Facial Plastic Surgery /ID# 270408
Redondo Beach, California, United States
Pacific Clinical Innovations /ID# 270414
Vista, California, United States
Center for Dermatology and Dermatologic Surgery /ID# 270390
Washington D.C., District of Columbia, United States
Skin Research Institute LLC /ID# 270410
Coral Gables, Florida, United States
DelRicht Research - New Orleans 308 /ID# 270425
New Orleans, Louisiana, United States
Boyd /Id# 270509
Birmingham, Michigan, United States
Luxurgery /ID# 270430
New York, New York, United States
Bellaire Dermatology Associates /ID# 270429
Bellaire, Texas, United States
Integrated Aesthetics /ID# 270399
Spring, Texas, United States
SkinDC /ID# 270411
Arlington, Virginia, United States
Countries
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Related Links
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Other Identifiers
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M24-704
Identifier Type: -
Identifier Source: org_study_id