Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device

Study Overview
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Brief Summary
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The intended use of the RF (radiofrequency) device used in this study is to assess the efficacy of the handpiece for the treatment of facial wrinkles. If the other device (Intense Pulsed Light) laser in this study is used, the intended use will be for the treatment of benign pigmented and/or vascular lesions.

Official Title
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Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device

Conditions
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Wrinkle, Benign Pigmented Lesions, Benign Vascular Lesions

Intervention / Treatment
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* Device: TempSure
* Device: Icon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy male or female 18 years of age or older. Agrees to be treated with the TempSure device. Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study. Understands and accepts the obligation and is logistically able to be present for all visits. Is willing to comply with all requirements of the study and sign the informed consent document. Exclusion Criteria: Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study. The subject has a cut, wound, or infected skin on the area to be treated. The subject is on local, oral, or systemic anesthetic agents. The subject has nerve insensitivity to heat in the treatment area. The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation. Exclusion Criteria for Icon Treatments Only: The subject is using systemic steroids (e.g. prednisone, dexamethasone) prior to or during the course of treatment. The subject has a medical condition or is receiving treatment that significantly compromise healing response. The subject has a history of light-induced seizures. The subject has a history of skin photosensitivity disorders. The subject has a history of hypertrophic scars or keloid formation. The subject has a history of radiation therapy in area to be treated.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One site will enroll patients to be treated with the the RF device, and the other site will enroll patients to be treated with the RF device and the Intense Pulsed Light (IPL) laser.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with RF Device<br>Subjects in this arm of the study will be treated with the radiofrequency device, and will receive up to 4 treatments on the face. | Device: TempSure<br>* This device is an RF device.<br>|
| Experimental: Treatment with IPL and RF Device<br>Subjects treated in this arm of the study will receive 2 treatments with just the radiofrequency device and then 2 treatments with both the radiofrequency and the IPL laser. | Device: TempSure<br>* This device is an RF device.<br>Device: Icon<br>* This device works with IPL (Intense Pulsed Light) handpieces.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Noticed Improvement | Subjects graded themselves on a scale ranging from Worsened to Very Much Improved at the follow up visit. The number of subjects who graded themselves as Improved was reported. | 12 week follow up |