Pivotal Study of the Cutera truSculpt Radiofrequency Device for Wrinkle Reduction

NCT ID: NCT03285581

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-15
• Study Completion Date: 2018-12-20

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.

Conditions

Wrinkle Reduction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

truSculpt RF

Subjects will receive RF treatments

Group Type: OTHER

truSculpt RF

Intervention Type: DEVICE

Subjects will receive RF treatments

Interventions

truSculpt RF

Subjects will receive RF treatments

Intervention Type: DEVICE

Other Intervention Names

Device: Treatment

Eligibility Criteria

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 -

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cutera Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Ronan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cutera Research Center

Daniel Friedmann, M.D.

Role: PRINCIPAL_INVESTIGATOR

Westlake Dermatology

Locations

Cutera Research Center

Brisbane, California, United States

Westlake Dermatology

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

C-17-TS14

Identifier Type: -

Identifier Source: org_study_id