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

NCT03424161 | Completed Results FDA Device

• 1 other identifier: C-18-SRF01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Quality

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Secret RF

OTHER

Treatment with Secret RF for skin quality

Device: Secret RF

Interventions

Secret RF DEVICE

Subjects will receive treatment with the Secret RF device

Secret RF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be able to read, understand and sign the Informed Consent Form.
• Female or Male, age 18 and older
• Willing to undergo treatments with Secret RF.
• 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.
• Subject must adhere to the follow-up schedule and study instructions.
• 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.
• 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.
• 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.

You may not qualify if:

• Participation in a clinical trial of another device or drug within 1 month of study participation, or during the study period.
• History of clotting disorders and/or current use of blood thinning medications.
• History of autoimmune disorders or diabetes.
• Cardiac pacemaker or active implantable metal device in the treatment area.
• Allergies to metals i.e. gold.
• Has a history of squamous cell carcinoma or melanoma in the treatment area.
• History of any disease or condition that could impair wound healing.
• History of keloid formation or abnormal/delayed wound healing.
• 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.
• Use of topical agents one week prior to treatment that may cause facial sensitivity.
• 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).
• 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.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (1)

Cutera Research Center

Brisbane, California, 94005, United States

Location

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-656-9612

Study Officials

• Stephen Ronan, MD

  Cutera Research Center

  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: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 6, 2018
• Study Start: January 10, 2018
• Primary Completion: October 8, 2018
• Study Completion: October 8, 2018
• Last Updated: September 15, 2023
• Results First Posted: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)