Pivotal Study of the Cutera truSculpt Radiofrequency Device for Wrinkle Reduction

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

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

Study Overview

• Status: Completed
• Conditions: Wrinkle Reduction
• Intervention / Treatment: Device: truSculpt RF

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Brisbane, California, United States, 94005
      • Cutera Research Center
  • Texas
    • Austin, Texas, United States, 78746
      • Westlake Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Must be able to understand and provide written informed consent and release of health information
2. Male or Female, 25 to 65 years of age (inclusive)
3. Fitzpatrick Skin Type I - VI (Appendix 4)
4. Has visible wrinkles or skin laxity in the treatment area
5. On the Fitzpatrick Classification Wrinkle Classification System subject has a pre-treatment score of 4-9 (inclusive) (Appendix 5)
6. No use of tobacco products for at least 6 months and willing to refrain from use for the duration of the study
7. 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
8. Subject must be willing to adhere to the follow-up schedule and study instructions
9. 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
10. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentations, educational, and/or marketing purposes
11. 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:

1. 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.
2. 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
3. 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
4. History of systemic steroid use within 3 months; history of topical steroid use in the target area within 2 months
5. History of systemic retinoid (isotretinoin) and therapeutic dose of Vitamin A within 6 months of study participation
6. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant
7. 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
8. 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
9. Diagnosed or documented immune system disorders
10. History of any disease or condition that could impair wound healing
11. History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen
12. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing
13. Infection, dermatitis, rash or other skin abnormality in the target area
14. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation
15. Anticipated or planned need for surgery or hospitalization during the duration of the study
16. 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
17. As per the Investigator's discretion, any physical or psychological condition which might make it unsafe for the subject to participate in this study -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: truSculpt RF; Subjects will receive RF treatments	Device: truSculpt RF; Subjects will receive RF treatments; Other Names: Device: Treatment

What is the study measuring?

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

Secondary 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 (76 - 100%), 3(Significant Improvement (51 - 75%), 2(Moderate Improvement (26 - 50%), 1(Mild Improvement (6 - 25%), 0(No Change (0 - 5%)	12 weeks post-final treatment
Principal Investigator's assessment of improvement at 12 weeks post-final treatment using the Alexiades Scale	Alexiades Scale=Categories of Skin Aging and Photodamage:Rhytides,Laxity,Elastosis and Texture (4=Severe; 2.5-3.5=Advanced;1.5-2.0=Moderate;1.0=Mild; 0=None)	12 weeks post-final treatment
Subject satisfaction level at 12 weeks post-treatment	Subject Satisfaction level and Assessment of Improvement in wrinkles and overall skin quality	12 weeks post-final treatment

Collaborators and Investigators

• Sponsor: Cutera Inc.
• Investigators: Principal Investigator: Daniel Friedmann, M.D., Westlake Dermatology; Principal Investigator: Stephen Ronan, M.D., Cutera Research Center

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: C-17-TS14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No