Status:
COMPLETED
Clinical Evaluation of Fractional Radiofrequency for the Treatment Acne Scarring
Lead Sponsor:
Venus Concept
Conditions:
Acne Scars
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of acne scarring. The study will evaluate the progress...
Eligibility Criteria
Inclusion
- Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their acne scarring.
- Able to read, understand and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- 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
- Implantable defibrillators, cardiac pacemakers, and other metal implants
- Subjects with any implantable metal device in the treatment area
- 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.
- Severe concurrent conditions, such as cardiac disorders.
- Pregnancy or intending to become pregnant during the study and nursing.
- 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 after a prophylactic regime has been followed for 2 weeks or longer prior to enrollment, or according to Investigator's discretion.
- Poorly controlled endocrine disorders, such as diabetes.
- 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 (excluding daily aspirin).
- Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
- Use of isotretinoin (Accutane®) or other systemic retinoids within six months or topical retinoids within three months prior to treatment; or as per physician's discretion.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen-containing agents) one week before and after each treatment session.
- Any surgical procedure in the treatment area within the last six months or before complete healing.
- Treating over tattoo or permanent makeup.
- 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.
Key Trial Info
Start Date :
December 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03821324
Start Date
December 11 2018
End Date
October 3 2019
Last Update
August 4 2023
Active Locations (1)
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1
Sadick Research Group
New York, New York, United States, 10075