Clinical Trial Search

Primary: Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase — 19; 0; 16; 0 Participants

Primary: Percentage of Composite Responders of at Least 2-Level Improvement of Severity — 20; 3 Participants

Primary: Investigator Global Assessment of Aesthetic Improvement — 0.7; 0.9; 1.1; 0.5 units on a scale

Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 58; 29; 43; 45 Participants

Primary: Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22 — 1.08; 1.10; 0.75; 0.50 score on a scale

Primary: The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh — 58 Participants

Primary: Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh — 85.7; 87.5…

Primary: 2-level Composite Responders for the Target Buttock — 16; 4; 194; 209 Participants — p=0.006

Primary: Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations — 11; 7; 4; 16 Investigator Assessments

Primary: Proportion of Subjects With ≥1-point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Buttocks) — 3; 2 Participants

Primary: Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders — 6; 131; 8; 125 Participants

Primary: 2-level Composite Responders for the Target Buttock — 12; 1; 202; 205 Participants — p=0.002

Primary: Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance. — 22.22; 33.33; 44.44 Percentage of participants

Primary: Change in Circumferential Measurements Over Time — -0.5; -1.0; -1.3; -2.0 cm

Primary: The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants — 1.5 score on a scale — p=.0001

Primary: Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) — 2.45 score on a scale

Primary: Percentage of Photographs Correctly Identified by Blinded Reviewers From the Independent Physician Reviewer Panel — 55.7 % of images identified correctly

Primary: Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel…

Primary: Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9 — 23; 4; 1…

Primary: Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel…

Primary: Number of Subjects That Met the Individual Success Criteria — 19; 3 participants — p=<0.0001

Primary: Mean Change (Decrease) in Cellulite Severity — 2.0; 1.8 units on a scale

Primary: Change in Weight From Baseline — 0.340 kilograms — p=0.473

Primary: Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 — 0; 0; 0; 0 Participants

Primary: Change in Aesthetic Appearance From Baseline — 0.97 score on a scale

Primary: Logarithm of Percentage of Baseline Ulcer Size — 3.6043; 3.5030 Mean of log (percentage of baseline area — p=0.652

Primary: Plasma AUX-I and AUX-II Concentrations — NA mmol/L

Primary: Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12. — -2.33 score on a scale

Primary: Number of Participants With Mild to Moderate Reduction in Cellulite. — 3; 2 participants

Primary: The Incidence of Any Grade 3 or Greater Event Intolerable Side Effect Experienced in a Cohort — 0; 0; 0 Participants