Fractional Radiofrequency for the Treatment and Reduction of Acne Scars and Wrinkles

Completed · Not applicable

Conditions studied: Acne Scars - Mixed Atrophic and Hypertrophic, Wrinkle

In brief

The objective of this clinical study is to evaluate the efficacy of fractional RF for the treatment and reduction of acne scarring or facial wrinkles.

Key facts

Study ID

NCT04057768

Run by

Venus Concept

People needed

10

Starts

2019-08-19

Expected to finish

2020-03-03

Last updated by the study team

2021-06-29

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their acne scarring or wrinkles.
• 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.

You may not qualify if…

• Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
• Subjects with any implantable metal device in the treatment area
• Permanent implant in the treated area, such as metal plates and screws (excluding dental implants), or an injected chemical substance.
• Current or history of any kind of cancer, or dysplastic nevi
• 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 following a prophylactic regime.
• 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 prior to treatment or as per investigators discretion.
• 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.

Where it is running

• Laser and Skin Surgery Center of Northern California — Sacramento, California, United States

Full record on ClinicalTrials.gov

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