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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 | Clinical Trials | Clareo Health

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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 in DIVERSITY: A Prospective, Open-label Study to Evaluate Subject Satisfaction With the Overall Face and Neck Appearance After Combined Treatment

NCT06783621•AbbVie

View on ClinicalTrials.gov

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

Age

22 - 65 years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

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.

Locations (10)

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

Key Dates

Start Date

January 16, 2025

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

December 23, 2025

Enrollment

130

ACTUAL participants

Conditions

Facial Contouring

Interventions

OnabotulinumtoxinA

DRUG

JUVÉDERM

DEVICE

CoolSculpting Elite System

DEVICE

SkinMedica Products

OTHER

KYBELLA

DRUG