Phase
Condition
N/ATreatment
KYBELLA
OnabotulinumtoxinA
CoolSculpting Elite System
Clinical Study ID
Ages 22-65 All Genders
Study Summary
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
Connect with a study center
Marcus Facial Plastic Surgery /ID# 270408
Redondo Beach, California 90277
United StatesActive - Recruiting
Pacific Clinical Innovations /ID# 270414
Vista, California 92083-6030
United StatesActive - Recruiting
Center for Dermatology and Dermatologic Surgery /ID# 270390
Washington, District of Columbia 20037-1495
United StatesActive - Recruiting
Skin Research Institute LLC /ID# 270410
Coral Gables, Florida 33146-1837
United StatesActive - Recruiting
DelRicht Research - New Orleans 308 /ID# 270425
New Orleans, Louisiana 70115
United StatesActive - Recruiting
Boyd /Id# 270509
Birmingham, Michigan 48009-6301
United StatesActive - Recruiting
Luxurgery /ID# 270430
New York, New York 10021
United StatesActive - Recruiting
Bellaire Dermatology Associates /ID# 270429
Bellaire, Texas 77401
United StatesActive - Recruiting
Integrated Aesthetics /ID# 270399
Spring, Texas 77388
United StatesActive - Recruiting
SkinDC /ID# 270411
Arlington, Virginia 22209
United StatesActive - Recruiting
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