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

• ClinicalTrials.gov Identifier: NCT03424161
• Recruitment Status: Recruiting
• First Posted: February 6, 2018
• Last Update Posted: February 12, 2018
• Sponsor: Cutera Inc.
• Information provided by (Responsible Party): Cutera Inc.

Tracking Information

• First Submitted Date: January 25, 2018
• First Posted Date: February 6, 2018
• Last Update Posted Date: February 12, 2018
• Actual Study Start Date: January 10, 2018
• Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 31, 2018)

• Improvement in Skin Quality Assessment [ Time Frame: Changes from Baseline at 4 weeks follow-up, and at 12 weeks follow-up ]
  Efficacy of treatment(s) with Cutera Secret RF measuring the changes in skin quality from Baseline to the 4 week follow-up visit, and from Baseline to the 12 week follow-up visit, as assessed by the study investigator using Skin Quality Rating Scale (1-10) for Radiance(1=No Radiance/worst to 10=maximum radiance/best), Smoothness(1=Very Rough/worst to 10=Very Smooth/best), Pigmentation(Very Irregular pigmentation/worst to 10=Very Uniform pigmentation/best), Erythema(1=Intense redness/worst to 10=No redness/best), and Pore size(1=Very Large pores/worst to 10=Minimal pores/best).
• Improvement in Acne Scar Assessment, if present [ Time Frame: Changes from Baseline at 4 weeks follow-up, and at 12 weeks follow-up ]
  Efficacy of treatment(s) with Cutera Secret RF measuring the changes in acne scarring from Baseline to the 4 week follow-up visit, and from Baseline to the 12 week follow-up visit, as assessed by the study investigator using ASAS: Acne scar Severity Assessment Scale if scars are present (+1=clear/best, +2=very mild, +3=mild, +4=moderate, or +5=severe/worst)
• Improvement in Wrinkle Assessment [ Time Frame: Changes from Baseline at 4 weeks follow-up, and at 12 weeks follow-up ]
  Efficacy of treatment(s) with Cutera Secret RF measuring the changes in number and depth of wrinkles from Baseline to the 4 week follow-up visit, and from Baseline to the 12 week follow-up visit as assessed by the study investigator using FWCS: Fitzpatrick Wrinkle Classification System (1-3=fine wrinkles, 4-6=moderate depth of wrinkles & moderate number of lines, 7-9=severe depth of wrinkles & numerous lines)
• Overall Aesthetic Improvement [ Time Frame: at 4 weeks follow-up and 12 weeks follow-up ]
  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 (≥75%), +3=Significant Improvement (50-74%), +2=Moderate Improvement (25-49%), +1=Mild Improvement (5-24%), or 0=No Change (<5%))

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03424161 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: January 31, 2018)

Device Safety [ Time Frame: through study completion, an average of 1+1/2 years ]

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Multi-Center, Clinical Evaluation of the Cutera Secret RF Device
• Official Title: Multi-Center, Clinical Evaluation of the Cutera Secret RF Device
• Brief Summary: The objectives of this study are to evaluate the efficacy and safety of the Cutera Secret RF device.
• Detailed Description: This is a multi-center, study in approximately 40 subjects, ages 18 to 65. Subjects may receive up to four treatments and will be followed at 4 and 12 weeks post the final treatment. A small subgroup of subjects may elect to have a biopsy of the treatment area prior to and after treatment. (Immediate, 72 Hours post initial treatment and 3 months post last treatment).
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Skin Quality

Intervention

Device: Secret RF

Subjects may receive up to 4 treatments

Study Arms

Secret RF

Treatment with Secret RF for skin quality

Intervention: Device: Secret RF

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 31, 2018): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2019
• Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Subject must be able to read, understand and sign the Informed Consent Form.
2. Female or Male, 18 to 65 years of age (inclusive).
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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Michaela Bell; 415-657-5722; mbell@cutera.com

Contact: Ginger Pocock; 415-657-5702; gpocock@cutera.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03424161
• Other Study ID Numbers: C-18-SRF01
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Cutera Inc.
• Study Sponsor: Cutera Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Stephen Ronan, MD; Cutera Research Center

• PRS Account: Cutera Inc.
• Verification Date: January 2018