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The purpose of this study is to evaluate hair reduction in the underarms in patients treated with the miraDry System.
This study is designed to quantify the amount of hair reduction in patients treated with the miraDry System in the axilla. Hair counts will be assessed before and after treatments including at follow up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group miraDry Treatment | Experimental | This is a single group study where each enrolled subject will receive active miraDry treatment in each axilla. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| miraDry Treatment | Device | Application of electromagnetic energy to heat the lower dermis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients with successful hair reduction | Percentage of patients that show a >=30% reduction in underarm hair at the 3 month visit compared to baseline. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patients with successful hair reduction | Percentage of patients that achieve a >=30% reduction in underarm hair at the 12 month visit compared to baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with hair reduction | Patients will provide their evaluation of satisfaction with the hair reduction seen | All follow-up visits through 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathy Quiroz, BS, RN | Miramar Labs, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zel Skin and Laser Specialists | Edina | Minnesota | 55424 | United States | ||
| Laser & Skin Surgery Center of NY |
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| New York |
| New York |
| 10016 |
| United States |
| Lehigh Valley Dermatology | Bethlehem | Pennsylvania | 18017 | United States |