Abdominoplasty, Breast Augmentation, Face Lift, Surgical Scar
Conditions
Keywords
Fractional Radiofrequency
Brief summary
Evaluator-blinded study of the safety and performance of fractional radiofrequency (FRF) for the treatment of surgical scars following breast augmentation, abdominoplasty or facelift. The study will enroll up to 50 female subjects requesting treatment of surgical scars following breast augmentation or abdominoplasty and up to 25 male and female subjects requesting treatment of surgical scars following facelift surgery. Subjects will receive a total of 3 treatments of their surgical scars at 1-month intervals. Subjects will be followed up at 10 months after their last treatment (12 months after the first treatment).
Interventions
DEVICEFractional Radiofrequency (FRF)
Fractional radiofrequency will be delivered to the area of the surgical scar.
Sponsors
Venus Concept
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The blinded reviewer will review the baseline photographs of the surgical scar(s) and compare them to the photographs taken at follow-up Month 12.
Intervention model description
The subject will act as their own control. Each surgical scar will be compared at the 12-month follow-up to the pre-treatment baseline.
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy, female, subjects 20-60 years of age who are seeking treatment for their breast augmentation or abdominoplasty surgical scars or male and female patients 40-75 years of age who are seeking treatment for their face lift surgical scars. 2. A minimum of four weeks since surgery. 3. Able to read, understand and voluntarily provide written Informed Consent. 4. Able and willing to comply with the treatment/follow-up schedule and requirements. 5. Willing to avoid direct sunlight for the duration of the study. 6. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.
Exclusion criteria
* 1\. Fitzpatrick skin types 5-6. 2. Implantable defibrillators, cardiac pacemakers, and other metal implants 3. Subjects with any implantable metal device in the treatment area 4. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant). 5\. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance. 6\. Current or history of any kind of cancer, or pre-malignant moles. 7. Severe concurrent conditions, such as cardiac disorders. 8. Pregnancy or intending to become pregnant during the study and nursing. 9. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications. 10\. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime. 11\. Poorly controlled endocrine disorders, such as diabetes. 12. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. 13\. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin. 14\. History of bleeding coagulopathies, or use of anticoagulants. 15. Use of isotretinoin (Accutane®) within six months prior to treatment. 16. Treating over tattoo or permanent makeup. 17. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks. 18\. As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of Surgical Scars at 12 Months Compared to Baseline (Pre-treatment) as Evaluated by 3 Independent Blinded Reviewers Using the General Aesthetic Improvement Scale (GAIS). The GAIS Ranges From 3 (Very Much Improved) to -3 (Very Much Worse). | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Surgical Scars at 12 Months as Evaluated by the Patients. | 12 months | Patient and Observer Scar Assessment Scale (POSAS) was used to evaluate the scar for pain, itching, color, stiffness, thickness, and appearance compared to their normal skin using a numbered scale. The scale ranges from 7 (no scar) to 70 with higher scores being worse and suggesting a worse scar. |
| Subject Satisfaction With Treatment | 12 months | Subjects will use the 5-point Likert Satisfaction scale where 4 is very satisfied, 3 is satisfied, 2 is having no opinion, 1 is unsatisfied and 0 is very unsatisfied to evaluate their satisfaction with the treatment. |
Countries
Spain
Participant flow
Pre-assignment details
3 subjects failed screening and were not treated in the study.
Participants by arm
| Arm | Count |
|---|---|
| FRF Treatment Each subject received 3 VivaMD treatments (monthly). | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | FRF Treatment |
|---|---|
| Age, Continuous | 47.5 years STANDARD_DEVIATION 0.2 |
| Race/Ethnicity, Customized Black | 1 Participants |
| Race/Ethnicity, Customized Brazilian (White&Black) | 1 Participants |
| Race/Ethnicity, Customized Central & South American | 2 Participants |
| Race/Ethnicity, Customized Eastern European | 5 Participants |
| Race/Ethnicity, Customized Iranian | 1 Participants |
| Race/Ethnicity, Customized Mediterranean | 19 Participants |
| Race/Ethnicity, Customized Western European | 22 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 3 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
Improvement of Surgical Scars at 12 Months Compared to Baseline (Pre-treatment) as Evaluated by 3 Independent Blinded Reviewers Using the General Aesthetic Improvement Scale (GAIS). The GAIS Ranges From 3 (Very Much Improved) to -3 (Very Much Worse).
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FRF Treatment | Improvement of Surgical Scars at 12 Months Compared to Baseline (Pre-treatment) as Evaluated by 3 Independent Blinded Reviewers Using the General Aesthetic Improvement Scale (GAIS). The GAIS Ranges From 3 (Very Much Improved) to -3 (Very Much Worse). | 1.66 units on a scale | Standard Deviation 0.71 |
Secondary
Assessment of Surgical Scars at 12 Months as Evaluated by the Patients.
Patient and Observer Scar Assessment Scale (POSAS) was used to evaluate the scar for pain, itching, color, stiffness, thickness, and appearance compared to their normal skin using a numbered scale. The scale ranges from 7 (no scar) to 70 with higher scores being worse and suggesting a worse scar.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FRF Treatment | Assessment of Surgical Scars at 12 Months as Evaluated by the Patients. | 13.4 units on a scale | Standard Error 1.2 |
| Baseline | Assessment of Surgical Scars at 12 Months as Evaluated by the Patients. | 28.3 units on a scale | Standard Error 1.4 |
Secondary
Subject Satisfaction With Treatment
Subjects will use the 5-point Likert Satisfaction scale where 4 is very satisfied, 3 is satisfied, 2 is having no opinion, 1 is unsatisfied and 0 is very unsatisfied to evaluate their satisfaction with the treatment.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FRF Treatment | Subject Satisfaction With Treatment | 3.4 units on a scale | Standard Deviation 1 |