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This study intended to investigate and compare the changes that may occur in response to cryolipolysis (localized cool exposure) and subcision (surgical technique) on cellulite. The cryolipolysis cooling device used is FDA approved for skin cooling, but still investigational in the treatment of cellulite. It has previously been used for fat reduction on love handles or back fat. During cryolipolysis, the system drew fat tissue into an applicator then exposes the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite. Subcision is a process used to treat scars left behind by acne or other skin diseases and has been noted to improve moderate to severe cellulite. Subcision is a simple surgical procedure that is performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together. This study was a pilot study designed to determine feasibility of these procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cryolipolysis | Experimental |
| |
| subcision | Active Comparator |
| |
| Control | Active Comparator | Areas with cellulite that had no treatment performed were considered the control arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cryolipolysis | Device | During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite |
| Measure | Description | Time Frame |
|---|---|---|
| Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance. | Two dermatologists blindly evaluated and compared the treated and control areas of each side at the final follow up visit (week 12). They rated the area with the best cosmetic appearance and reported the percentages of participants for whom "Cryolipolysis" or "Subcision" resulted in the "best cosmetic appearance". It was possible for raters to determine that neither treatment outperformed the other, thereby rating the control arm better. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine, Department of Dermatology | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Receiving Split Body Treatment | The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision. cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Receiving Split Body Treatment | The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision. cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance. | Two dermatologists blindly evaluated and compared the treated and control areas of each side at the final follow up visit (week 12). They rated the area with the best cosmetic appearance and reported the percentages of participants for whom "Cryolipolysis" or "Subcision" resulted in the "best cosmetic appearance". It was possible for raters to determine that neither treatment outperformed the other, thereby rating the control arm better. | Posted | Number | 90% Confidence Interval | Percentage of participants | 12 weeks |
|
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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 | Cryolipolysis | cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| small ulcer | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Murad Alam | Northwestern University | 312-695-4761 | m-alam@northwestern.edu |
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| ID | Term |
|---|---|
| D000071697 | Cellulite |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Subcision | Procedure | Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together. |
|
| Control | Other |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Subcision | Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together. |
| OG002 | Control | Area that received no treatment |
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Subcision | Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together. | 0 | 22 | 3 | 22 |
| EG002 | Control | Nothing was done to the area. | 0 | 22 | 0 | 22 |
| lumps | General disorders |
|
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