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



Status:Recruiting
Healthy:No
Age Range:18 - 65
Updated:2/14/2018
Start Date:January 10, 2018
End Date:May 2019
Contact:Michaela Bell
Email:mbell@cutera.com
Phone:415-657-5722

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

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).

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.
We found this trial at
1
site
Brisbane, California 94005
Principal Investigator: Stephen Ronan, MD
Phone: 415-657-5544
?
mi
from
Brisbane, CA
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