Multi-Center, Clinical Evaluation of the Cutera Secret RF Device

The objectives of this study are to evaluate the efficacy and safety of the Cutera Secret RF device.

Study Overview

• Status: Completed
• Conditions: Skin Quality
• Intervention / Treatment: Device: Secret RF

Detailed Description

This is a multi-center, study in approximately 40 subjects, ages 18 and older. Subjects will receive treatments and will be followed at 4 and 12 weeks post the final treatment.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Brisbane, California, United States, 94005
      • Cutera Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subject must be able to read, understand and sign the Informed Consent Form.
2. Female or Male, age 18 and older
3. Willing to undergo treatments with Secret RF.
4. Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period.
5. Subject must adhere to the follow-up schedule and study instructions.
6. Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the treatment area during the study and has no intention of having such procedures performed during the course of the study.
7. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes.
8. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control prior to enrollment and during the entire course of the study.

Exclusion Criteria:

1. Participation in a clinical trial of another device or drug within 1 month of study participation, or during the study period.
2. History of clotting disorders and/or current use of blood thinning medications.
3. History of autoimmune disorders or diabetes.
4. Cardiac pacemaker or active implantable metal device in the treatment area.
5. Allergies to metals i.e. gold.
6. Has a history of squamous cell carcinoma or melanoma in the treatment area.
7. Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion.
8. History of any disease or condition that could impair wound healing.
9. History of keloid formation or abnormal/delayed wound healing.
10. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
11. Use of topical agents one week prior to treatment that may cause facial sensitivity.
12. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).
13. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: Secret RF; Treatment with Secret RF for skin quality	Device: Secret RF; Subjects will receive treatment with the Secret RF device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Aesthetic Improvement	Efficacy of treatment(s) with Cutera Secret RF measuring the global skin improvement at the 4 week follow-up visit, and at the 12 week follow-up visit as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change Higher scores indicate better outcomes	at 4 weeks follow-up and 12 weeks follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Safety	Safety of the Cutera Secret RF laser as measured by the frequency and severity (0=none, 1=mild, 2=moderate, or 3=severe) of device related adverse events.	through study completion, an average of 1+1/2 years

Collaborators and Investigators

• Sponsor: Cutera Inc.
• Investigators: Principal Investigator: Stephen Ronan, MD, Cutera Research Center

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): October 8, 2018
• Study Completion (Actual): October 8, 2018

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: C-18-SRF01

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