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)

AbbVie

Status and phase: Enrolling; Phase 4

Conditions: Facial Contouring

Treatments: Drug: KYBELLA; Device: CoolSculpting Elite System; Drug: OnabotulinumtoxinA; Other: SkinMedica Products; Device: JUVÉDERM

Study type: Interventional

Funder types: Industry

Identifiers

NCT06783621

M24-704

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No 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
  • 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Cohort 1: Open-Label Combination Treatments

Experimental group

Description:

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).

Treatment:

Device: JUVÉDERM

Other: SkinMedica Products

Drug: OnabotulinumtoxinA

Device: CoolSculpting Elite System

Drug: KYBELLA

Cohort 2: Open-Label Combination Treatments

Experimental group

Description:

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).

Treatment:

Device: JUVÉDERM

Other: SkinMedica Products

Drug: OnabotulinumtoxinA