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

Cutera Inc.2 sites in 1 country39 target enrollmentAugust 15, 2017

ConditionsWrinkle Reduction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Wrinkle Reduction
Sponsor: Cutera Inc.
Enrollment: 39
Locations: 2
Primary Endpoint: Principal Investigator's Assessment of Improvement at 12 Weeks Post-final Treatment (Physician's Global Assessment of Improvement=GAIS)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

August 15, 2017

End Date

December 20, 2018

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cutera Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Principal Investigator's Assessment of Improvement at 12 Weeks Post-final Treatment (Physician's Global Assessment of Improvement=GAIS)

Time Frame: 12 weeks post-final treatment

GAIS: 4=Very Significant Improvement, 3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement, 0=No Change Higher scores indicate better outcomes