Evaluating patient satisfaction with facial and neck appearance after various cosmetic treatments

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

This study is testing how happy people are with their facial and neck appearance after trying different cosmetic treatments like Botox and fillers.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 22 Years to 65 Years
• Sex: All
• Sponsor: AbbVie (industry)
• Locations: 10 sites (Redondo Beach, California and 9 other locations)
• Trial ID: NCT06783621 on ClinicalTrials.gov

What this trial studies

This study assesses patient satisfaction regarding the appearance of their face and neck following a combination of cosmetic treatments, including onabotulinumtoxinA, JUVÉDERM products, KYBELLA, CoolSculpting Elite, and SkinMedica products. Participants will be evaluated based on their satisfaction levels after receiving these interventions, which aim to enhance facial contouring. The study will involve a diverse population to ensure a comprehensive understanding of treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals seeking cosmetic enhancements for facial contouring and who meet specific severity criteria for various facial lines and volume deficits.

Not a fit: Patients who do not have moderate to severe facial aesthetic concerns or who are not seeking cosmetic treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of combined cosmetic treatments for improving patient satisfaction with facial aesthetics.

How similar studies have performed: Other studies have shown positive outcomes with similar cosmetic treatment combinations, indicating a potential for success in this approach.

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.

Where this trial is running

Redondo Beach, California and 9 other locations

• Marcus Facial Plastic Surgery /ID# 270408 — Redondo Beach, California, United States (RECRUITING)
• Pacific Clinical Innovations /ID# 270414 — Vista, California, United States (RECRUITING)
• Center for Dermatology and Dermatologic Surgery /ID# 270390 — Washington, District of Columbia, United States (RECRUITING)
• Skin Research Institute LLC /ID# 270410 — Coral Gables, Florida, United States (RECRUITING)
• DelRicht Research - New Orleans 308 /ID# 270425 — New Orleans, Louisiana, United States (RECRUITING)
• Boyd /Id# 270509 — Birmingham, Michigan, United States (RECRUITING)
• Luxurgery /ID# 270430 — New York, New York, United States (RECRUITING)
• Bellaire Dermatology Associates /ID# 270429 — Bellaire, Texas, United States (RECRUITING)
• Integrated Aesthetics /ID# 270399 — Spring, Texas, United States (RECRUITING)
• SkinDC /ID# 270411 — Arlington, Virginia, United States (RECRUITING)

Study contacts

• Study coordinator: ABBVIE CALL CENTER

Conditions: Facial Contouring, OnabotulinumtoxinA, JUVEDERM Products, KYBELLA, CoolSculpting Elite, SkinMedica