CoolSculpting® System
DeviceEach participant underwent a single treatment session that was comprised of timed segments of cooling followed by 2 minutes of manual massage.
NCT Number: NCT04142450
To evaluate the safety and effectiveness of the Allergan CoolSculpting® system using CoolAdvantage applicators for non-invasive subcutaneous fat reduction of the upper arms and inner thighs in participants of Chinese descent.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Pacific Derm, Vancouver, British Columbia, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each participant underwent a single treatment session that was comprised of timed segments of cooling followed by 2 minutes of manual massage.
Time frame: Baseline (Day 1) to Week 12
Baseline versus 12-week images of the participants' left and right upper arms were assessed separately by the reviewers. Success was defined as at least 75% correct identification of the pre-treatment images of the upper arms.
Time frame: Baseline (Day 1) to Week 12
Baseline versus 12-week images of the participants' left and right thighs were assessed separately by the reviewers. Success was defined as at least 75% correct identification of the pre-treatment images of the inner thighs.
Time frame: Week 12
Participants were asked to complete a survey upon completing the treatment to assess their level of satisfaction with the treatment. Participants selected one of five options: 'very satisfied', 'satisfied', 'neither satisfied nor dissatisfied', 'dissatisfied', or 'very dissatisfied'.
Time frame: Week 12
Participants were asked to complete a survey upon completing the treatment to assess their level of satisfaction with the treatment. Participants selected one of five options: 'very satisfied', 'satisfied', 'neither satisfied nor dissatisfied', 'dissatisfied', or 'very dissatisfied'.
Time frame: Baseline (Day 1) to Week 12
Caliper measurements of the treatment areas were taken at baseline and at 12-weeks post treatment. After the treatment area was identified and marked, the thickness of the fat layer was measured using a caliper at the middle of the fat bulge. For each treatment area, three measurements were taken and recorded. The average of the three measurements was calculated. A negative change from baseline indicates improvement.
Time frame: Baseline (Day 1) to Week 12
Caliper measurements of the treatment areas were taken at baseline and at 12-weeks post treatment. After the treatment area was identified and marked, the thickness of the fat layer was measured using a caliper at the middle of the fat bulge. For each treatment area, three measurements were taken and recorded. The average of the three measurements was calculated. A negative change from baseline indicates improvement.
Allergan
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01859091
Body Fat Disorder
Pleasanton, California, United States
View Trial DetailsNCT03352141
Body Fat Disorder
Vancouver, British Columbia, Canada
View Trial DetailsNCT02081209
Body Fat Disorder
Marina del Rey, California, United States
View Trial DetailsNCT03738891
Body Fat Disorder
Marina del Rey, California, United States
View Trial Details