Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift

Clinical Evaluation of the Safety and Performance of Fractional RF for the Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift

Split-body/face evaluator-blind study of the safety and performance of fractional RF for the treatment of surgical scars following breast augmentation, abdominoplasty or face lift. 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 face lift surgery. Subjects will receive a total of three treatments of their surgical scars at one-month intervals on one side of the body or face only. Subjects will be followed up at one, two, three and ten months after their last treatment. Outcomes will be compared to the non-treated side.

Study Overview

• Status: Completed
• Conditions: Breast Augmentation; Abdominoplasty; Face Lift; Surgical Scar
• Intervention / Treatment: Device: fractional radiofrequency

Detailed Description

Blinded evaluators to determine the efficacy of the study treatment by comparing baseline photographs with photographs taken at follow up months 3, 4, 5 and 12 using the Global Aesthetic Improvement scale (GAIS), Manchester Scar Scale (MSS) and Patient and Observer Scar assessment scale (POSAS).

Study subjects will also complete a Patient and Observer Scar assessment scale (POSAS) and 5-Point Likert Satisfaction Scale at baseline and at follow-up month 5 and 12, indicating their satisfaction with the study treatment.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Marbella, Spain
    • Ocean Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fractional radiofrequency; Each surgical scar will be divided equally into two sections. One section of the scar will receive the study treatment while the other section will receive no study treatment for the duration of the study.	Device: fractional radiofrequency; Fractional radiofrequency will be delivered to the area of the surgical scar identified to receive the study treatment.
No Intervention: No fractional radiofrequency; Each surgical scar will be divided equally into two sections. One section of the scar will receive the study treatment while the other section will receive no study treatment for the duration of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treating surgical scar tissue to improve appearance as evaluated by an independent blinded reviewer at 3 months and 10 months post treatment to assess the treatment efficacy.	A blinded reviewer will analyze the photographs taken at baseline, at study visit 3 months from the study start and 10 months from study start to determine the efficacy of treatment using the 7-point General Aesthetic Improvement Scale (GAIS) where 3 is very much improved, 2 is much improved, 1 is improved, 0 is no change, -1 is worse, -2 is much worse and -3 is very much worse and the Manchester Scar Scale where the scar is evaluated by colour, surface appearance, contour, distortion and texture using a numbered scale.	3 months and 10 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in appearance of surgical scars at 1 and 2 months post-treatment	Evaluated by the independent reviewer using the 7-point General Aesthetic Improvement Scale (GAIS) where 3 is very much improved, 2 is much improved, 1 is improved, 0 is no change, -1 is worse, -2 is much worse and -3 is very much worse and the Manchester Scar Scale where the scar is evaluated by colour, surface appearance, contour, distortion and texture using a numbered scale.	1 and 2 months
Assessment of surgical scars at 3 and 10 months post-treatment to assess the efficacy of treatment	Patient and Observer Scar Assessment Scale (POSAS) will be used by the independent blinded reviewer to assess the efficacy of the treatment where the scar is evaluated on its vascularity, pigmentation, thickness, relief, pliability and surface area using a numbered scale. The subject will assess the scar with respect to pain, itching, color, stiffness, thickness and appearance compared to their normal skin using a numbered scale.	3 and 10 months post treatment
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.	3 and 10 months post treatment

Collaborators and Investigators

• Sponsor: Venus Concept
• Investigators: Principal Investigator: Kai O. Kaye, Ocean Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2018
• Primary Completion (Actual): April 13, 2020
• Study Completion (Actual): April 13, 2020

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: March 9, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Fractional Radiofrequency
• Other Study ID Numbers: CS0717

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No