Skin Quality
Conditions
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.
Interventions
DEVICESecret RF
Subjects will receive treatment with the Secret RF device
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Aesthetic Improvement | 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, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change Higher scores indicate better outcomes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Secret RF Treatment with Secret RF for skin quality | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Secret RF |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 27 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
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
Time frame: at 4 weeks follow-up and 12 weeks follow-up
Population: 3 subjects has GAIS measurements available at both the 4 and 12 week follow ups 5 subjects had GAIS measurements only available at the 4 week follow up 2 subjects had GAIS measurements only available at the 12 week follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secret RF | Overall Aesthetic Improvement | GAIS at the 4 week follow up | 1.63 score on a scale | Standard Deviation 0.92 |
| Secret RF | Overall Aesthetic Improvement | GAIS at the 12 week follow up | 2 score on a scale | Standard Deviation 0.71 |