Thigh Circumference Reduction Study (NCT00953290) | Clinical Trial Compass
TerminatedNot Applicable
Thigh Circumference Reduction Study
Stopped: The study was terminated because the preliminary data did not indicate efficacy.
United States4 participantsStarted 2009-01
Plain-language summary
The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Body Mass Index between 20 and 35
* Presence of cellulite grades II, III or IV according to GLD scale
* Visible bi-lateral thigh fat Thigh area to be treated to measure at least 30.0mm in vertical fold, as measured with industry standard fat caliper
* Subject must be able to read, understand and sign the Consent Form
* Subject must adhere to the follow-up schedule and study instructions
* Subject must adhere to the same diet and/or exercise routine throughout the study
Exclusion Criteria:
* Significant weight fluctuation (+/-10 lbs) in the past 6 months
* Taking weight-loss medications/supplements
* Participation in any other clinical study
* Cellulite treatment within 3 months of the treatment
* Surgical or non-surgical treatments to the target area in the last 12 months, e.g., liposuction
* Prior treatment to the target area within the last 12 months
* Arteriosclerosis or weakened blood vessels
* Heart disease
* Thromboembolic disease
* Diagnosed or documented immune system disorders
* Bleeding disorders.
* Presence of uncontrolled hypertension
* Taking prescription anticoagulants
* History of keloid formation
* Malignant tumors in the target area
* Diabetes
* Any disease or condition that could impair wound healing
* Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars
* Infection in the target area
* Implanted electrical device(s)
* Pregnant or lactating
What they're measuring
1
Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms
Timeframe: Baseline and 6 months post final treatment
2
Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms
Timeframe: Baseline and 6 months post final treatment