Clinical trial NCT03424161: Multi-Center, Clinical Evaluation of the Cutera Secret RF Device
Official title: Multi-Center, Clinical Evaluation of the Cutera Secret RF Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Quality
Lead sponsor: Cutera Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 and older. Subjects will receive treatments and will be followed at 4 and 12 weeks post the final treatment.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Aesthetic Improvement
timeFrame: at 4 weeks follow-up and 12 weeks follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: United States
facility: Cutera Research Center
state: California
Study officials:
affiliation: Cutera Research Center
name: Stephen Ronan, MD
role: PRINCIPAL_INVESTIGATOR
References: