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Prospective, non-randomized, open-label study to evaluate the dermal cooling system for cryotherapy of common skin conditions.
The purpose of this study is to establish that controlled localized cooling with the Dermal Cooling System will elicit an improvement in the cosmetic appearance of benign superficial lesions associated with common skin conditions that are currently being treated with cryosurgical methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with cryotherapy | Experimental | Dermal Cooling System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermal Cooling System | Device | Cryotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in appearance in the treatment area | Improvement in appearance in the treated area at the 3-month follow-up visit, as determined by the Physician Global Assessment (PGA). | 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of procedure related adverse events | • Safety of the treatment as determined by the incidence of device- or procedure-related serious adverse events | less than 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristine Tatsutani, PhD | R2 Dermatology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clear Dermatology & Aesthetics Center | Scottsdale | Arizona | 85255 | United States | ||
| Zel Skin and Laser Specialists |
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| Edina |
| Minnesota |
| 55424 |
| United States |
| Dermatology, Laser and Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | United States |