Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03424161
Other study ID # C-18-SRF01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2018
Est. completion date October 8, 2018

Study information

Verified date September 2023
Source Cutera Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date October 8, 2018
Est. primary completion date October 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Secret RF
Subjects will receive treatment with the Secret RF device

Locations

Country Name City State
United States Cutera Research Center Brisbane California

Sponsors (1)

Lead Sponsor Collaborator
Cutera Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT04128046 - The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation N/A
Completed NCT04172740 - RADIESSE Injection in Perioral and Marionette Lines N/A
Not yet recruiting NCT05595525 - Laser Treatment to Improve Skin Quality N/A
Completed NCT03097835 - Evaluation of Skin Quality Improvement Phase 2
Active, not recruiting NCT05747690 - Evaluation of Performance and Safety of KIO015 in Face Skin Hydration Improvement N/A