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The purpose of this study is to evaluate whether the Dermal Cooling System can be used to elicit an improvement in the cosmetic appearance or physical symptoms of common skin conditions.
This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the Dermal Cooling system to determine if cosmetic benefits or physical symptoms are achieved in common skin conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Dermal Cooling System | Experimental | Dermal Cooling System will be used in all eligible subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermal Cooling System | Device | Controlled localized cooling may be applied to lesions using the Dermal Cooling System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in appearance in the treated area as determined by the Physician Global Assessment (PGA). | Investigator assessment using Physician Global Assessment (PGA); graded from "4" (very much improved") to "0" (worse). | up to 3 months |
| Incidence of treatment-emergent adverse events | The safety of the treatment is determined by the incidence of device- or procedure-related serious adverse events. | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristine Tatsutani, PhD | R2 Technologies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Research | Dublin | California | 94568 | United States | ||
| Oak Dermatology |
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| Naperville |
| Illinois |
| 60563 |
| United States |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | United States |
| Dermatology, Laser and Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | United States |