Pivotal Study of the Cutera truSculpt Radiofrequency Device for Wrinkle Reduction

Study Overview
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Brief Summary
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The purpose of this pivotal investigation is to evaluate the safety and efficacy of the Cutera truSculpt™ radiofrequency (RF) Device for Wrinkle Reduction.

Detailed Description
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This is an Open-label, Prospective, Multicenter Pivotal Study of approximately 40 male or female subjects, age 25 to 65 years who desire RF treatment for wrinkle reduction and improvement in skin quality. Subjects will receive RF treatments with the Cutera truSculpt™ radiofrequency (RF) device. Subjects will return to the site after study treatments have been delivered 12 weeks post-final treatment.

Official Title
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Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction

Conditions
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Wrinkle Reduction

Intervention / Treatment
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* Device: truSculpt RF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be able to understand and provide written informed consent and release of health information Male or Female, 25 to 65 years of age (inclusive) Fitzpatrick Skin Type I - VI (Appendix 4) Has visible wrinkles or skin laxity in the treatment area On the Fitzpatrick Classification Wrinkle Classification System subject has a pre-treatment score of 4-9 (inclusive) (Appendix 5) No use of tobacco products for at least 6 months and willing to refrain from use for the duration of the study Subject must agree to not undergo any other cosmetic procedure(s) area, or start topical retinol products in the treatment area during the study period Subject must be willing to adhere to the follow-up schedule and study instructions Subject must be willing to adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study, within 10% of baseline weight measurement Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentations, educational, and/or marketing purposes For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant - Exclusion Criteria: Participation in a clinical trial of a drug or another device in the target area within 3 months of study participation, or during the study. Any type of prior cosmetic treatment to the target area within 12 months of study participation e.g., radiofrequency, cryolipolysis, deoxycholate injection, or light-based treatments Prior injection of botulinum toxin, collagen, hyaluronic acid filler, or other dermal filler, and medium-depth to deep chemical peels, to the treatment area within 6 months of study participation History of systemic steroid use within 3 months; history of topical steroid use in the target area within 2 months History of systemic retinoid (isotretinoin) and therapeutic dose of Vitamin A within 6 months of study participation Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant Has metal implant(s) within the body that are local to the treatment area, such as surgical clips, plates and screws (metal tooth fillings or crowns will not exclude subject participation), or has , artificial heart valves or artificial joints Clinically significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders that in the opinion of the Investigator will confound participation in the study Diagnosed or documented immune system disorders History of any disease or condition that could impair wound healing History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing Infection, dermatitis, rash or other skin abnormality in the target area Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation Anticipated or planned need for surgery or hospitalization during the duration of the study Pregnant, nursing, or planning a pregnancy during the trial; or is a woman of child bearing potential but is not willing to use an acceptable method of contraception as determined by the Investigator As per the Investigator's discretion, any physical or psychological condition which might make it unsafe for the subject to participate in this study -

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: truSculpt RF<br>Subjects will receive RF treatments | Device: truSculpt RF<br>* Subjects will receive RF treatments<br>* Other names: Device: Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Principal Investigator's Assessment of Improvement at 12 Weeks Post-final Treatment (Physician's Global Assessment of Improvement=GAIS) | GAIS: 4=Very Significant Improvement, 3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement, 0=No Change Higher scores indicate better outcomes | 12 weeks post-final treatment |