ACTIVE_NOT_RECRUITING

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

Conditions

Facial Contouring OnabotulinumtoxinA JUVEDERM Products KYBELLA CoolSculpting Elite SkinMedica

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-01-16

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06783621

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Principal Investigator

ABBVIE INC.

STUDY_DIRECTOR

AbbVie

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: AbbVie

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-16

Study Completion Date2026-03

Study Record Updates

Study Start Date2025-01-16

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

Facial Contouring
OnabotulinumtoxinA
JUVEDERM Products
KYBELLA
CoolSculpting Elite
SkinMedica

Additional Relevant MeSH Terms

Facial Contouring