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

NCT ID: NCT03467724

Last Updated: 2024-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-23
• Study Completion Date: 2020-04-13

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fractional radiofrequency (FRF)

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

Group Type: EXPERIMENTAL

Fractional Radiofrequency (FRF)

Intervention Type: DEVICE

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

Interventions

Fractional Radiofrequency (FRF)

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Venus Concept

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kai O. Kaye

Role: PRINCIPAL_INVESTIGATOR

Ocean Clinic

Locations

Ocean Clinic

Marbella, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CS0717

Identifier Type: -

Identifier Source: org_study_id