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The primary objective of this pilot study is exploratory investigation evaluating the Potenza microneedle fractional radiofrequency (RF) device and may be used in combination with the Icon intense pulsed light (IPL) device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | This group is Potenza treatments only. |
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| Group B | Experimental | This group is Potenza and Icon treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potenza | Device | Subjects will receive 1-4 treatments at approximately 1 month intervals, but other intervals from 2 to 12 weeks may take place at the PI's discretion. At the discretion of the PI, additional follow-up visits may take place to observe the time course of skin reactions after treatment and/or to assess if the skin condition continues to improve beyond 3 months after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Grading of Skin Aging and Photodamage | At the 90 day follow up, subjects will be graded on a scale of 0-4 (0 being none and 4 being severe) for the presence of skin aging and photodamage. The # of subjects with improvement will be reported. | 90 days post last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic | San Diego | California | 92130 | United States |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D057896 | Striae Distensae |
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
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Randomization is not requires, as the group to which a subject is assigned to will be at the discretion of the investigator.
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| Icon | Device | Subjects will receive 1-4 treatments at approximately 1 month intervals, but other intervals from 2 to 12 weeks may take place at the PI's discretion. At the discretion of the PI, additional follow-up visits may take place to observe the time course of skin reactions after treatment and/or to assess if the skin condition continues to improve beyond 3 months after treatment. |
|
| D012816 | Signs and Symptoms |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |