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To evaluate the safety, and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the temporary improvement in the appearance of cellulite.
Multi-site clinical study to evaluate the safety, efficacy and tolerability of Soliton's Rapid Acoustic Pulse (RAP) device fo the temporary improvement in the appearance of cellulite.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAP Treatment | Experimental | Each treatment area will receive 30-40 minutes (30-40 individual doses) of RAP treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soliton's Rapid Acoustic Pulse (RAP) | Device | Treatment for the temporary improvement in the appearance of cellulite. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Safety- All treated participants are free from unexpected adverse events | The primary objective is to demonstrate freedom from unexpected adverse events (UAEs) and serious adverse events (SAEs) directly attributable to the RAP device or treatment. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| RAP treatment effectiveness | To demonstrate temporary improvement in the appearance of cellulite as determined by blinded independent physician assessment (IPA) correctly identifying the 12-week post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. | 12 weeks, 26 weeks and 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
This study is specific to females ages 18-50 years.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Capelli, MD | Soliton, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clear Dermatology and Aesthetics Center Investigate MD | Scottsdale | Arizona | 85255 | United States | ||
| Chicago Cosmetic Surgery & Dermatology |
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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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| Chicago |
| Illinois |
| 60654 |
| United States |
| Capital Laser and Skin Care | Chevy Chase | Maryland | 20815 | United States |
| SkinCare Physicians | Chestnut Hill | Massachusetts | 02467 | United States |