Effects on Cellulite Appearance (NCT04876118) | Clinical Trial Compass
CompletedNot Applicable
Effects on Cellulite Appearance
United States97 participantsStarted 2020-11-13
Plain-language summary
Evaluate the safety and feasibility effecting the appearance of cellulite on the thigh using CoolSculpting.
Who can participate
Age range22 Years – 65 Years
SexFEMALE
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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
* Female subjects \> 22 years of age and \< 65 years of age.
* Subject has clearly visible cellulite on the intended treatment area (thighs), which in the Investigator's opinion, may benefit from the treatment.
* Subject has not had weight change exceeding 5% in the preceding month.
* Subject agrees to maintain her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
* Subject has read and signed a written informed consent form.
Exclusion Criteria
* Subject has had a surgical procedure(s) in the area of intended treatment.
* Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
* Subject has had a non-invasive fat reduction, body contouring, cellulite reduction and/or skin tightening procedure in the area of intended treatment within the past 4 months.
* Presence of significant suntan in the thighs.
* Inability to avoid sun exposure in the thighs.
* Subject has a history of hernia in or adjacent to the areas to be treated.
* Subject needs to administer or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
* Subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
* Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits …
What they're measuring
1
Percentage of Photographs Correctly Identified by Blinded Reviewers From the Independent Physician Reviewer Panel
Timeframe: Week 12 post final treatment (up to 24 weeks after first treatment)