A Study to Evaluate Patient Satisfaction With the Overall Face and Neck Appearance After Combined… (NCT06783621) | Clinical Trial Compass
CompletedPhase 4
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
United States130 participantsStarted 2025-01-16
Plain-language 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.
Who can participate
Age range22 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 medic…
What they're measuring
1
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Satisfaction with Facial Appearance Scale at the Final Visit