Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions

Conditions
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Wrinkles, Scars, Stretch Marks, Pigmentation, Skin Laxity

Intervention / Treatment
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* Device: Potenza
* Device: Icon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female 18 years of age or older. Presence of unwanted dermatologic condition suitable for treatment such as facial and/or neck wrinkles, skin laxity of face, neck or body, scars, acne scars or striae, or Vascular and/or pigment dyschromia Ability to read, understand, and sign the Informed Consent Form Understands and accepts the obligation not to undergo any other procedures in the areas to be treated and/or weight loss through the follow-up period. Willing and able to comply with all study participation requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study Exclusion Criteria: Is pregnant or of childbearing potential and not using (or willing to use) medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study. Presence of an active systemic or local skin disease or condition that may affect wound healing or interfere with participation. History of keloids or poor wound healing Taking medication which is known to increase sensitivity to sunlight Has a seizure disorders triggered by light Cancer, malignant disease, skin pathology, condition or allergic reactions that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments History of collagen, vascular or immunosuppressive or deficiency disorders History of coagulative disorder or use of anticoagulant drugs within 2 weeks of study treatment Use of steroids within 2 weeks of study treatments Use of Accutane (isotretinoin) in the past 12 months Previous surgical or cosmetic procedure to the target area in the last 6 to 12 months that could interfere with the treatment procedure and affect treatment outcome Has an implanted pacemaker or defibrillator, metal pins or prosthetic joints Allergic reaction to gold metal Receiving or have received gold therapy Photo-sensitive skin Psycho-neurotic condition including alcohol or drug abuse Unwilling or unable to adhere to all study requirements for treatment and follow-up 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.

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: Randomization is not requires, as the group to which a subject is assigned to will be at the discretion of the investigator.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>This group is Potenza treatments only. | Device: Potenza<br>* 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.<br>|
| Experimental: Group B<br>This group is Potenza and Icon treatments. | Device: Potenza<br>* 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.<br>Device: Icon<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |