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

Launched by ABBVIE · Jan 15, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how satisfied participants are with the overall appearance of their face and neck after receiving a combination of cosmetic treatments. These treatments include OnabotulinumtoxinA (often known as Botox), JUVÉDERM® fillers, KYBELLA (for reducing chin fat), CoolSculpting Elite (a non-invasive fat reduction method), and selected SkinMedica skincare products. The goal is to see how these combined treatments can improve facial contouring and enhance patient satisfaction in a diverse group of participants.

To join the study, participants should be aged between 35 and 74 and meet certain criteria related to facial appearance, such as having noticeable wrinkles or volume loss in specific areas of the face. However, individuals with certain health conditions, allergies, or a history of specific cosmetic procedures may not be eligible. Those who participate can expect to receive these treatments and share their feedback on how they feel about their appearance afterward. This information will help researchers understand the overall effectiveness of these combined treatments in enhancing facial aesthetics.

Gender

ALL

Eligibility criteria

• 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 with submental fat:
• • - 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.
• • Current use or planned treatment with weight loss medications during the study (including but not limited to glucagon-like peptide-1 agonists, or glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 agonists).
• • History of body weight change of \> 10% over the 6 months prior to screening, or anticipated body weight change of \> 10% during the study period.