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The goal of the energy-based devices used in this study is to evaluate their safety and performance to treat unwanted dermatologic conditions.
Up to 50 subjects will be enrolled at 1 study center. Subjects will be enrolled into 4 groups: Group A, Group B, Group C, or Group D. Subjects may enroll in more than one group, however the last treatment in the previous group would be at least 30 days before the subject is enroll in the next group if treatment area is the same.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPL only | Experimental | Group A will be treated with an intense pulsed light (IPL) device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar IPL device that is cleared for use by the FDA. |
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| RF Microneedling Only | Experimental | Group B will be treated with a radiofrequency (RF) microneedling device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar RF microneedling device that is cleared for use by the FDA. |
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| RF Only | Experimental | Group C will be treated with an RF device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar RF device that is cleared for use by the FDA. |
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| Combination | Experimental | Group D will receive combination treatments and will be treated with 2 or more of the study devices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intense pulsed light. | Device | The intense pulsed light (IPL) will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum pain reported during treatment. | The maximum pain during treatment per each device will be reported on a scale of 0(none) to 10 (maximum intolerable pain). This pain is recorded during when the patient is actively treated (when the patient comes in and receives a treatment from the device). | procedure (during device treatment)] |
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Inclusion Criteria:
Exclusion Criteria:
Radiofrequency Device Only:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamie Trimper | Contact | 9782564200 | jamie.trimper@cynosure.com |
| Name | Affiliation | Role |
|---|---|---|
| Sean Doherty | Cynosure, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cynosure | Recruiting | Westford | Massachusetts | 01886 | United States |
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| ID | Term |
|---|---|
| D062325 | Intense Pulsed Light Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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Subjects will be treated with an intended pulsed light device. Subjects may also receive split treatments where one side of the face and/or body will be treated with the study device, and the contralateral side will be treated with a similar IPL device or a similar microneedling device. Randomization will not be used as the group the subject will be assigned to will be determined based on dermatologic condition the subject presents with and this will be determined by the Investigator.
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| Radiofrequency microneedling device | Device | The microneedling device will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands. |
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| Radiofrequency device | Device | The radio frequency device will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands. |
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| Combined energy devices | Device | The combined energy devices will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands. |
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