Fat Disorder
Conditions
Brief summary
The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.
Detailed description
The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat using the Zeltiq Dermal Cooling device.
Interventions
Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Sponsors
Zeltiq Aesthetics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female subjects \> 18 years of age. 2. Subject has clearly visible fat on the flanks, thighs, abdomen, or back. 3. Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month. 4. Subject has read and signed a written informed consent form.
Exclusion criteria
1. Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years. 2. Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months. 3. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. 4. Subject is taking diet pills within the past 6 months. 5. Subject is unable or unwilling to comply with the study requirements. 6. Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation. 7. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 8. Patient is pregnant or intending to become pregnant in the next 9 months. 9. Patient is lactating or has been lactating in the past 9 months. 10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fat Layer Thickness of the Treated Flank | Baseline and 6 months | The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group. |
| Percentage of Subjects Expressing Satisfaction With the Procedure | 6 months post-treatment follow-up visit | Subject satisfaction as determined by the completion of a questionnaire at the 6 month follow-up visit, and, as requested, any other follow-up visits. |
| Percentage of Correctly Identified Pre-treatment Photographs | Baseline and 6 months | Change in the treated vs. untreated areas will be assessed for changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the control and treated flanks. Reviewers will be practicing dermatologists. All reviewers will be blinded to post-treatment vs. baseline and/or untreated flank. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form.Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. Results reflect the percentage of correctly identified images. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group 1 Subjects in Treatment Group 1 were treated using a Cooling Intensity Factor (CIF) of 33 for 60 minutes. | 28 |
| Treatment Group 2 Subjects in Treatment Group 2 were treated using CIF 37 for 30 minutes. | 11 |
| Treatment Group 3 Subjects in Treatment Group 3 were treated using CIF 37 for 45 minutes. | 11 |
| Treatment Group 4 Subjects in Treatment Group 4 were treated using CIF 42 for 30 minutes. | 10 |
| Total | 60 |
Baseline characteristics
| Characteristic | Treatment Group 2 | Treatment Group 3 | Treatment Group 1 | Treatment Group 4 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 11 Participants | 27 Participants | 9 Participants | 58 Participants |
| Age, Continuous | 44 years | 44 years | 41 years | 49 years | 44 years |
| Region of Enrollment United States | 11 participants | 11 participants | 28 participants | 10 participants | 60 participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 1 Participants | 5 Participants | 19 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 27 Participants | 5 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 11 | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 1 / 28 | 1 / 11 | 1 / 11 | 1 / 10 |
| serious Total, serious adverse events | 0 / 28 | 0 / 11 | 0 / 11 | 0 / 10 |
Outcome results
Primary
Change in Fat Layer Thickness of the Treated Flank
The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group.
Time frame: Baseline and 6 months
Population: The population includes only subjects with evaluable ultrasound data ( \>3 valid images at 6 month follow up visit). Group 1 exclusions: 2 Lost To Follow Up and 6 not evaluable; Group 2 exclusions: 1 not evaluable; Group 3 exclusions: 3 not evaluable; Group 4 exclusions: 1 not evaluable and 1 withdrawn from study by Investigator.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Groups | Change in Fat Layer Thickness of the Treated Flank | -18.7 percent fat layer change | Standard Error 1.9 |
| Group 1 | Change in Fat Layer Thickness of the Treated Flank | -22.6 percent fat layer change | Standard Error 3.4 |
| Group 2 | Change in Fat Layer Thickness of the Treated Flank | -17.8 percent fat layer change | Standard Error 3.6 |
| Group 3 | Change in Fat Layer Thickness of the Treated Flank | -17.5 percent fat layer change | Standard Error 2.3 |
| Group 4 | Change in Fat Layer Thickness of the Treated Flank | -11.1 percent fat layer change | Standard Error 3.8 |
95% CI: [14.9, 22.4]
Primary
Percentage of Correctly Identified Pre-treatment Photographs
Change in the treated vs. untreated areas will be assessed for changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the control and treated flanks. Reviewers will be practicing dermatologists. All reviewers will be blinded to post-treatment vs. baseline and/or untreated flank. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form.Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. Results reflect the percentage of correctly identified images.
Time frame: Baseline and 6 months
Population: The analysis population included subjects who had evaluable photos from baseline and the 6 month final follow-up visit. Subjects who did not maintain their weight per protocol requirements were excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Groups | Percentage of Correctly Identified Pre-treatment Photographs | 91.9 percent correctly identified images | Standard Error 5.2 |
| Group 1 | Percentage of Correctly Identified Pre-treatment Photographs | 90.5 percent correctly identified images | Standard Error 7.6 |
| Group 2 | Percentage of Correctly Identified Pre-treatment Photographs | 100 percent correctly identified images | Standard Error 0 |
| Group 3 | Percentage of Correctly Identified Pre-treatment Photographs | 100 percent correctly identified images | Standard Error 0 |
| Group 4 | Percentage of Correctly Identified Pre-treatment Photographs | 83.3 percent correctly identified images | Standard Error 15.2 |
Primary
Percentage of Subjects Expressing Satisfaction With the Procedure
Subject satisfaction as determined by the completion of a questionnaire at the 6 month follow-up visit, and, as requested, any other follow-up visits.
Time frame: 6 months post-treatment follow-up visit
Population: 56 subjects completed the questionnaire; 2 subjects were LTFU, 1 subject failed to complete the questionnaire and 1 subject was withdrawn from the study by the Investigator. Four (4) subjects did not respond to one question on the questionnaire; 1 subject did not respond to another question on the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Groups | Percentage of Subjects Expressing Satisfaction With the Procedure | Expectations were met or exceeded | 73.2 percent positive responses | Standard Deviation 5.9 |
| All Groups | Percentage of Subjects Expressing Satisfaction With the Procedure | Overall satisfaction with treatment experience | 82.1 percent positive responses | Standard Deviation 5.1 |
| All Groups | Percentage of Subjects Expressing Satisfaction With the Procedure | Discomfort was no greater than expected | 98.2 percent positive responses | Standard Deviation 1.8 |
| All Groups | Percentage of Subjects Expressing Satisfaction With the Procedure | Agree there is a change to the treated area | 76.3 percent positive responses | Standard Deviation 5.7 |
| All Groups | Percentage of Subjects Expressing Satisfaction With the Procedure | Agree change to treated area was improvement | 78.9 percent positive responses | Standard Deviation 5.7 |
| Group 1 | Percentage of Subjects Expressing Satisfaction With the Procedure | Expectations were met or exceeded | 72 percent positive responses | Standard Deviation 9 |
| Group 1 | Percentage of Subjects Expressing Satisfaction With the Procedure | Agree change to treated area was improvement | 95.2 percent positive responses | Standard Deviation 4.7 |
| Group 1 | Percentage of Subjects Expressing Satisfaction With the Procedure | Agree there is a change to the treated area | 84 percent positive responses | Standard Deviation 7.3 |
| Group 1 | Percentage of Subjects Expressing Satisfaction With the Procedure | Discomfort was no greater than expected | 100 percent positive responses | Standard Deviation 0 |
| Group 1 | Percentage of Subjects Expressing Satisfaction With the Procedure | Overall satisfaction with treatment experience | 84 percent positive responses | Standard Deviation 7.3 |
| Group 2 | Percentage of Subjects Expressing Satisfaction With the Procedure | Agree change to treated area was improvement | 63.6 percent positive responses | Standard Deviation 14.5 |
| Group 2 | Percentage of Subjects Expressing Satisfaction With the Procedure | Overall satisfaction with treatment experience | 81.8 percent positive responses | Standard Deviation 11.6 |
| Group 2 | Percentage of Subjects Expressing Satisfaction With the Procedure | Agree there is a change to the treated area | 54.5 percent positive responses | Standard Deviation 15 |
| Group 2 | Percentage of Subjects Expressing Satisfaction With the Procedure | Expectations were met or exceeded | 78.6 percent positive responses | Standard Deviation 12.4 |
| Group 2 | Percentage of Subjects Expressing Satisfaction With the Procedure | Discomfort was no greater than expected | 90.9 percent positive responses | Standard Deviation 8.7 |
| Group 3 | Percentage of Subjects Expressing Satisfaction With the Procedure | Discomfort was no greater than expected | 100 percent positive responses | Standard Deviation 0 |
| Group 3 | Percentage of Subjects Expressing Satisfaction With the Procedure | Overall satisfaction with treatment experience | 90.9 percent positive responses | Standard Deviation 8.7 |
| Group 3 | Percentage of Subjects Expressing Satisfaction With the Procedure | Expectations were met or exceeded | 81.8 percent positive responses | Standard Deviation 11.6 |
| Group 3 | Percentage of Subjects Expressing Satisfaction With the Procedure | Agree change to treated area was improvement | 81.8 percent positive responses | Standard Deviation 11.6 |
| Group 3 | Percentage of Subjects Expressing Satisfaction With the Procedure | Agree there is a change to the treated area | 100 percent positive responses | Standard Deviation 0 |
| Group 4 | Percentage of Subjects Expressing Satisfaction With the Procedure | Agree change to treated area was improvement | 55.6 percent positive responses | Standard Deviation 16.6 |
| Group 4 | Percentage of Subjects Expressing Satisfaction With the Procedure | Expectations were met or exceeded | 66.7 percent positive responses | Standard Deviation 15.7 |
| Group 4 | Percentage of Subjects Expressing Satisfaction With the Procedure | Overall satisfaction with treatment experience | 66.7 percent positive responses | Standard Deviation 15.7 |
| Group 4 | Percentage of Subjects Expressing Satisfaction With the Procedure | Discomfort was no greater than expected | 100 percent positive responses | Standard Deviation 0 |
| Group 4 | Percentage of Subjects Expressing Satisfaction With the Procedure | Agree there is a change to the treated area | 55.6 percent positive responses | Standard Deviation 16.6 |