Pivotal Study of the Cutera truSculpt Radiofrequency Device for Wrinkle Reduction

NCT03285581 | Completed Results FDA Device

• 1 other identifier: C-17-TS14
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Wrinkle Reduction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

truSculpt RF

OTHER

Subjects will receive RF treatments

Device: truSculpt RF

Interventions

truSculpt RF DEVICE

Subjects will receive RF treatments

Also known as: Device: Treatment

truSculpt RF

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (2)

Cutera Research Center

Brisbane, California, 94005, United States

Location

Westlake Dermatology

Austin, Texas, 78746, United States

Location

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-656-9612

Study Officials

• Stephen Ronan, M.D.

  Cutera Research Center

  PRINCIPAL INVESTIGATOR

• Daniel Friedmann, M.D.

  Westlake Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 18, 2017
• Study Start: August 15, 2017
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: September 13, 2023
• Results First Posted: September 13, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)