Status:
COMPLETED
Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift
Lead Sponsor:
Venus Concept
Conditions:
Surgical Scar
Breast Augmentation
Eligibility:
All Genders
20-75 years
Phase:
NA
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 e...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2020
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03467724
Start Date
January 23 2018
End Date
April 13 2020
Last Update
July 29 2024
Active Locations (1)
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1
Ocean Clinic
Marbella, Spain