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

NCT03467724 | Completed Results

• 1 other identifier: CS0717
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Surgical Scar; Breast Augmentation; Abdominoplasty; Face Lift

Keywords

Fractional Radiofrequency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Assessment of Surgical Scars at 12 Months as Evaluated by the Patients.

  12 months

• Subject Satisfaction With Treatment

  12 months

Study Arms (1)

Fractional radiofrequency (FRF)

EXPERIMENTAL

Subjects received 3 FRF treatments (monthly) over their scar following breast augmentation, abdominoplasty or face lift surgery.

Device: Fractional Radiofrequency (FRF)

Interventions

Fractional Radiofrequency (FRF) DEVICE

Fractional radiofrequency will be delivered to the area of the surgical scar.

Fractional radiofrequency (FRF)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Gender Eligibility Details: Only female subjects are eligible for surgical scar treatment following breast augmentation and abdominoplasty. Both men and women are eligible for facelift scar treatments.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• A minimum of four weeks since surgery.
• Able to read, understand and voluntarily provide written Informed Consent.
• Able and willing to comply with the treatment/follow-up schedule and requirements.
• Willing to avoid direct sunlight for the duration of the study.
• 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.

You may not qualify if:

• \. 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).
• \. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
• \. 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.
• \. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
• \. Poorly controlled endocrine disorders, such as diabetes. 12. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• \. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
• \. 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.
• \. As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

Ocean Clinic

Marbella, Spain

Location

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Venus Concept

mgronski@venusconcept.com

1-888-907-0115

Study Officials

• Kai O. Kaye

  Ocean Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: March 16, 2018
• Study Start: January 23, 2018
• Primary Completion: April 13, 2020
• Study Completion: April 13, 2020
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-02

Locations

ES (1)