Clinical trial NCT03467724: Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift
Official title: Clinical Evaluation of the Safety and Performance of Fractional RF for the Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Scar
Breast Augmentation
Abdominoplasty
Face Lift
Keywords: Fractional Radiofrequency
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2018-03-16
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: 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).
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of Surgical Scars at 12 Months as Evaluated by the Patients.
timeFrame: 12 months
measure: Subject Satisfaction With Treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Marbella
country: Spain
facility: Ocean Clinic
Study officials:
affiliation: Ocean Clinic
name: Kai O. Kaye
role: PRINCIPAL_INVESTIGATOR
References: