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A double-blind, placebo-controlled randomized evaluation of the effect of Cellulize, a green light low level laser system for aesthetic use for the non-invasive reduction in fat layer for body contouring and reduction of cellulite.
This clinical trial will provide objective evidence showing effectiveness of the Cellulize 532nm green light therapy for the non-invasive reduction in fat layer for body contouring, and for the non-invasive treatment for the appearance of cellulite.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cellulize 532nm | No Intervention | Cellulize device using 532nm Green Light. | |
| Cellulize Placebo (Sham Comparator) | Sham Comparator | Cellulize modified to appear as if it is running, but does not use the 532nm light. "Sham" Device, or "Placebo." |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham Comparator | Device | A modified device utilizing a pigtail connector to bypass active treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Inches of Total Circumference Measurements | Average Change in Inches of Total Circumference Measurements for effect of Cellulize, a LED 532nm green light low level laser system for aesthetic use for the non-invasive reduction in fat layer for body contouring from baseline measurements, and after treatment. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Durability of Effect | Durability of Effect: a term used to indicate whether the results of the primary outcome endure at the 2 week follow up time point. If the average change in inches of total circumference continues decreasing or stays the same, then the durability of effect is assumed to endure for at least two weeks. If the measurements at the 2-week time point show that the changes in inches return to previous measures at the start of treatment, then the effect is considered temporary. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert H Burke, MD | Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wunderlich Chiropractic Clinic | Cape Coral | Florida | 33904 | United States | ||
| Mobile Laser Slimming |
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Patients randomly assigned to either the active 532nm treatment group, or the sham device (placebo) group using a modified device rigged to not treat patients.
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| 2 weeks |
| Change in appearance of cellulite | Change in appearance of cellulite is a measure of the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. | 2 weeks |
| Cocoa Beach |
| Florida |
| 32931 |
| United States |
| Lake Mary Health and Wellness | Lake Mary | Florida | 32714 | United States |
| Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan | Ann Arbor | Michigan | 48104 | United States |