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Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite
To assess the safety and tolerability of Soliton's RAP Nov Heavy for the treatment of cellulite. To assess the efficacy of Soliton's RAP Nov Heavy device for the temporary improvement in appearance of cellulite in terms of mean change in cellulite severity score (CSS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAP treatment | Other | Single RAP treatment applied to thigh and multi-treatment applied to the other thigh. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soliton Rapid Acoustic Pulse (RAP) | Device | Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SAEs | The primary safety endpoint will be met if all treated Participants are free from serious adverse events (SAEs) attributable to the RAP device immediately post treatment and at the 3-month follow-up visit. | 18 weeks |
| Treatment Tolerability | The primary endpoint will be met if a mean tolerability measure using pain scores averaged across all treated Participants is < 8.0 | 18 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cellulite improvement | A ≥15% mean reduction in the 0-5-point Cellulite Severity Scale as determined by physician assessment of Participant photographs taken before and 3 months after treatment. | 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher C Capelli, MD | Soliton | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SkinCare Physicians | Chestnut Hill | Massachusetts | 02467 | 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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Single Group
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