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

Last updated: April 7, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

KYBELLA

OnabotulinumtoxinA

CoolSculpting Elite System

Clinical Study ID

NCT06783621
M24-704
  • Ages 22-65
  • All Genders

Study 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

Inclusion Criteria:

Applies to All Participants:

  • Must meet at least 1 of the following criteria for BOTOX UFL treatment perinvestigator'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 elevationand Moderate or Severe on Allergan Glabellar Line Severity Scale at maximumfurrow

  • Moderate or severe on Lateral Canthal Line Severity Scale at maximumcontraction (identical severity on both sides)

  • Must meet at least 3 of the following criteria for treatment in the face with atleast 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 KYBELLAtreatment) or Moderate, severe, or extreme (For CoolSculpting Elite treatment) perinvestigator's assessment.

Exclusion

Exclusion Criteria:

  • History of medical condition that may put the subject at increased medical risk withexposure to OnabotulinumtoxinA, including diagnosed myasthenia gravis, Eaton-Lambertsyndrome, amyotrophic lateral sclerosis, or any other condition that might interferewith neuromuscular function.

  • History of hypersensitivity or allergy to any botulinum toxin serotype,Streptococcal protein, lidocaine (or any amide-based anesthetics), HA products, anyother excipients or constituents of the study drug, device, SkinMedica productsand/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, excessivelyphotodamaged skin, or the inability to substantially lessen facial lines even byphysically spreading them apart.

  • Previous plastic surgery, tissue grafting, permanent facial implants (e.g.,polymethylmethacrylate, silicone, polytetrafluoroethylene), or tissue augmentationwith silicone, fat, or other permanent dermal fillers of the face and/or neck orplan 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 6months prior to screening.

  • Prior treatment with non-permanent soft tissue fillers or fat-reducing injectablesin 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 othernoninvasive fat reduction procedure and/or skin-tightening laser treatments in theface 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-dependentinsulinotropic polypeptide/glucagon-like peptide-1 agonists).

  • History of body weight change of > 10% over the 6 months prior to screening, oranticipated body weight change of > 10% during the study period.

Study Design

Total Participants: 100
Treatment Group(s): 5
Primary Treatment: KYBELLA
Phase: 4
Study Start date:
January 16, 2025
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Marcus Facial Plastic Surgery /ID# 270408

    Redondo Beach, California 90277
    United States

    Active - Recruiting

  • Pacific Clinical Innovations /ID# 270414

    Vista, California 92083-6030
    United States

    Active - Recruiting

  • Center for Dermatology and Dermatologic Surgery /ID# 270390

    Washington, District of Columbia 20037-1495
    United States

    Active - Recruiting

  • Skin Research Institute LLC /ID# 270410

    Coral Gables, Florida 33146-1837
    United States

    Active - Recruiting

  • DelRicht Research - New Orleans 308 /ID# 270425

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • Boyd /Id# 270509

    Birmingham, Michigan 48009-6301
    United States

    Active - Recruiting

  • Luxurgery /ID# 270430

    New York, New York 10021
    United States

    Active - Recruiting

  • Bellaire Dermatology Associates /ID# 270429

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Integrated Aesthetics /ID# 270399

    Spring, Texas 77388
    United States

    Active - Recruiting

  • SkinDC /ID# 270411

    Arlington, Virginia 22209
    United States

    Active - Recruiting

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