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| Name | Class |
|---|---|
| Zeltiq Aesthetics | INDUSTRY |
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This is a prospective randomized controlled study comparing the efficacy of cryolipolysis versus a combination of cryolipolysis and surgical subcision for the treatment of cellulite. The treatment sites are both outer thighs. One outer thigh will be randomized to receive one treatment of cryolipolysis, while the contralateral thigh will be assigned to receive the combination cryolipolysis plus surgical subcision. A live rating by a blinded dermatologist will evaluate the treatment and control areas using a cellulite severity scale at week 0 (before treatment) and at the 3-month follow up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cyrolipolysis | Active Comparator |
| |
| cryolipolysis plus subcision | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyrolipolysis (CoolSculpting device) | Procedure | Treatment will be a cold exposure for up to 120 minutes using the CoolSculpting device with a commercially available treatment setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Live rating by a blinded dermatologist using cellulite severity scale | The cellulite severity scale rates cellulite 1-5 as mild, 6-10 as moderate, and 11-15 as severe. | Change from Baseline in cellulite severity scale at 3 months |
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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 | Term |
|---|---|
| D000071697 | Cellulite |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| subcision | Procedure | The skin will be punctured using a subcision needle to cut the septa responsible for the skin depression after cryolipolysis. |
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