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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoolSculpting® System | Experimental | Participants underwent a single CoolSculpting® treatment session on Day 1 that was comprised of timed segments of cooling followed by 2 minutes of manual massage. Each treated arm had up to two timed segments (or cycles) in the treatment session, each treated thigh had one timed segment (or cycle) in the treatment session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoolSculpting® System | Device | Each participant underwent a single treatment session that was comprised of timed segments of cooling followed by 2 minutes of manual massage. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Arms With Correct Identification of Baseline Versus 12-week Treatment Images of the Upper Arms by at Least Two Out of Three Blinded, Independent Reviewers | 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. | Baseline (Day 1) to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Thighs With Correct Identification of Baseline Versus 12-week Treatment Images of the Inner Thighs by at Least Two Out of Three Blinded, Independent Reviewers | 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. | Baseline (Day 1) to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Hickling | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver Laser and Skin Care Clinic | Vancouver | British Columbia | V5Z 1H2 | Canada | ||
| Project Skin MD |
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| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. | View source |
| To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link. | View source |
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Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
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| ID | Title | Description |
|---|---|---|
| FG000 | CoolSculpting® System | Participants underwent a single CoolSculpting® treatment session on Day 1 that was comprised of timed segments of cooling followed by 2 minutes of manual massage. Each treated arm had up to two timed segments (or cycles) in the treatment session, each treated thigh had one timed segment (or cycle) in the treatment session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety Population included all treated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | CoolSculpting® System | Participants underwent a single CoolSculpting® treatment session on Day 1 that was comprised of timed segments of cooling followed by 2 minutes of manual massage. Each treated arm had up to two timed segments (or cycles) in the treatment session, each treated thigh had one timed segment (or cycle) in the treatment session. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Arms With Correct Identification of Baseline Versus 12-week Treatment Images of the Upper Arms by at Least Two Out of Three Blinded, Independent Reviewers | 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. | Per Protocol Population, consisted of all treated participants followed for 12 weeks and with weight change of no more than 5% of total body weight at the time the 12-week images were taken. Overall number analyzed are the number of participants and number of arms treated per protocol with data available for analyses. | Posted | Number | 95% Confidence Interval | percentage of arms | Baseline (Day 1) to Week 12 | arms | arms |
|
Day 1 Treatment to Week 12 +/- 14 days
Protocol provided an extensive, detailed list of well-known anticipated device effects which were not considered adverse events (AEs) unless severity caused disruption to the participant's daily activities, or lasted longer than anticipated duration, in which case they were evaluated as potential AEs. Safety Population included all treated participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CoolSculpting® System | Participants underwent a single CoolSculpting® treatment session on Day 1 that was comprised of timed segments of cooling followed by 2 minutes of manual massage. Each treated arm had up to two timed segments (or cycles) in the treatment session, each treated thigh had one timed segment (or cycle) in the treatment session. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 2, 2019 | Feb 25, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 2, 2019 | Feb 25, 2021 | SAP_001.pdf |
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This is an open-label study. Blinding will only be employed for photograph review by an independent panel of physician reviewers with expertise in the areas of dermatology and/or plastic surgery.
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| Number of Participants With a Response of 'Satisfied' or 'Very Satisfied' for Question 1 (Overall Satisfaction) on the CoolSculpting Participant Questionnaire at the 12-week Visit for the Upper Arms | 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'. | Week 12 |
| Number of Participants With a Response of 'Satisfied' or 'Very Satisfied' for Question 1 (Overall Satisfaction) on the CoolSculpting Participant Questionnaire at the 12-week Visit for the Inner Thighs | 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'. | Week 12 |
| Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Upper Arms | 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. | Baseline (Day 1) to Week 12 |
| Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Inner Thighs | 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. | Baseline (Day 1) to Week 12 |
| Vancouver |
| British Columbia |
| V6H 1K9 |
| Canada |
| Pacific Derm | Vancouver | British Columbia | V6H 4E1 | Canada |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Secondary | Percentage of Thighs With Correct Identification of Baseline Versus 12-week Treatment Images of the Inner Thighs by at Least Two Out of Three Blinded, Independent Reviewers | 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. | Per Protocol Population consisted of all treated participants followed for 12 weeks and with weight change of no more than 5% of total body weight at the time the 12-week images were taken. Overall number analyzed are the number of participants and number of thighs treated per protocol with data available for analyses. | Posted | Number | 95% Confidence Interval | percentage of thighs | Baseline (Day 1) to Week 12 | thighs | thighs |
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| Secondary | Number of Participants With a Response of 'Satisfied' or 'Very Satisfied' for Question 1 (Overall Satisfaction) on the CoolSculpting Participant Questionnaire at the 12-week Visit for the Upper Arms | 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'. | Per Protocol Population consisted of all treated participants followed for 12 weeks and with weight change of no more than 5% of total body weight at the time the 12-week images were taken. Number of participants analyzed are the number of participants with arms treated with data available for analyses. | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Number of Participants With a Response of 'Satisfied' or 'Very Satisfied' for Question 1 (Overall Satisfaction) on the CoolSculpting Participant Questionnaire at the 12-week Visit for the Inner Thighs | 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'. | Per Protocol Population consisted of all treated participants followed for 12 weeks and with weight change of no more than 5% of total body weight at the time the 12-week images were taken. Number of participants analyzed is the number of participants with thighs treated with data available for analyses. | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Upper Arms | 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. | Per Protocol Population consisted of all treated participants followed for 12 weeks and with weight change of no more than 5% of total body weight at the time the 12-week images were taken. Overall number analyzed are the number of participants and number of arms treated per protocol with data available for analyses. | Posted | Mean | Standard Deviation | millimeter (mm) | Baseline (Day 1) to Week 12 | arms | arms |
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| Secondary | Change From Baseline in Mean Fat Reduction Using Caliper Measurements at Week 12 for Inner Thighs | 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. | Per Protocol Population consisted of all treated participants followed for 12 weeks and with weight change of no more than 5% of total body weight at the time the 12-week images were taken. Overall number analyzed are the number of participants and number of thighs treated per protocol available for analyses. | Posted | Mean | Standard Deviation | mm | Baseline (Day 1) to Week 12 | thighs | thighs |
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| 49 |
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.