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OnabotulinumtoxinA & JUVÉDERM®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

Sponsor:

AbbVie

Code:

NCT06783621

Conditions

Facial Contouring

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Interventions

OnabotulinumtoxinA

JUVÉDERM

CoolSculpting Elite System

SkinMedica Products

KYBELLA

Study Details

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.

Conditions

Facial Contouring

Study ID

NCT06783621

Start date

Jan 16, 2025

Status verified date

Oct, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

130 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

experimental: Cohort 2: Open-Label Combination Treatments

Interventions

OnabotulinumtoxinA

Intramuscular Injections

JUVÉDERM

Injections

CoolSculpting Elite System

CoolSculpting Elite Applicator

SkinMedica Products

Skincare Product

KYBELLA

Injections

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

Locations

Marcus Facial Plastic Surgery /ID# 270408

Recruiting

Redondo Beach, California, United States, 90277

Pacific Clinical Innovations /ID# 270414

Recruiting

Vista, California, United States, 92083-6030

Center for Dermatology and Dermatologic Surgery /ID# 270390

Recruiting

Washington D.C., District of Columbia, United States, 20037-1495

Skin Research Institute LLC /ID# 270410

Recruiting

Coral Gables, Florida, United States, 33146-1837

DelRicht Research - New Orleans 308 /ID# 270425

Recruiting

New Orleans, Louisiana, United States, 70115

Boyd /Id# 270509

Recruiting

Birmingham, Michigan, United States, 48009-6301

Luxurgery /ID# 270430

Recruiting

New York, New York, United States, 10021

Bellaire Dermatology Associates /ID# 270429

Recruiting

Bellaire, Texas, United States, 77401

Integrated Aesthetics /ID# 270399

Recruiting

Spring, Texas, United States, 77388

SkinDC /ID# 270411

Recruiting

Arlington, Virginia, United States, 22209

More Information

Sponsor

AbbVie

Last update posted

Oct 27, 2025

Last verified

Oct, 2025

Keywords

Facial Contouring
OnabotulinumtoxinA
JUVEDERM Products
KYBELLA
CoolSculpting Elite
SkinMedica

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by AbbVie on 2025-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.