Effects on Cellulite Appearance

Not Applicable

Completed

Brief Summary: Evaluate the safety and feasibility effecting the appearance of cellulite on the thigh using CoolSculpting.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Fat Reduction	The ZELTIQ System	The treatments are designed to see if the appearance of cellulite can be reduced on the outer thigh with a new applicator design.

Primary Outcome Measures

Name	Time	Method
Percentage of Photographs Correctly Identified by Blinded Reviewers From the Independent Physician Reviewer Panel	Week 12 post final treatment (up to 24 weeks after first treatment)	Photographs of the treatment area taken at baseline and 12-weeks after final treatment were assessed for visual changes. Reported here is the mean percentage (%) of correct baseline identification of images by the blinded independent reviewers.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)	Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)	An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious AE was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An adverse devise effect (ADE) was any sign, symptom, or disease determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of a serious AE.

Locations (6): Investigate MD
🇺🇸
Scottsdale, Arizona, United States
Rebecca Fitzgerald, MD Dermatology
🇺🇸
Los Angeles, California, United States
Aesthetic Solutions, P.A.
🇺🇸
Chapel Hill, North Carolina, United States
Sasaki Advanced Aesthetics Medical Center
🇺🇸
Pasadena, California, United States
Laser and Skin Surgery Center of Northern California
🇺🇸
Sacramento, California, United States
Innovation Research Center
🇺🇸
Pleasanton, California, United States