Bipolar Radiofrequency with Vacuum Apparatus in the Treatment of Acne Scars

Michael H. Gold, MD, Gold Skin Care Center, Tennessee Clinical Research Center Inc., Nashville, Tennessee, USA

Julie A. Biron, BS, Tennessee Clinical Research Center Inc., Nashville, Tennessee, USA


ABSTRACT

The use of bipolar radiofrequency (RF) with an associated vacuum device allows for precise deep dermal heating of the collagen followed by collagen remodeling. It has been successfully used in clinical trials for the treatment of rhytides and skin laxity. The present (in-progress) clinical trial examined the effects of a bipolar RF device with vacuum in the treatment of facial acne scars. Twenty patients are receiving six weekly treatments with the RF device. Patients are being followed for 3 months after their last treatment. Fourteen patients have completed six treatments and their results are reported. Improvement after the fourth treatment was noticeable in 10 of 14 subjects and equal to or stronger in the sixth treatment than before the fourth treatment in 10 subjects. Twelve subjects were at least slightly satisfied with the treatment and 4 subjects were very satisfied or extremely satisfied with the treatment. Discomfort during treatment was minimal and adverse effects were limited to mild and temporary erythema. The bipolar RF with vacuum devices appears to be a safe and effective method for reducing mild to moderate facial acne scars.

Introduction

Acne affects up to 80% of people aged 11 to 30 years and up to 5% of older adults. In severe cases, subject response to Propionibacterium acnes results in permanently disfiguring scars1 that can also have a significant negative impact on self-esteem. Non-surgical treatments include creams, peels, fillers, non-ablative lasers, and radiofrequency (RF) devices. Surgical treatments include microdermabrasion, dermabrasion, photorejuvenation, scar revision, and resurfacing. Combination treatments have also proven effective. RF energy has been used in surgical, cardiological, neurological, and orthopedic applications that involve heat-induced injury to collagen.2-7 Several dermatological studies have tested the use of RF energy in ablative resurfacing of human skin.8-10 RF devices are minimally invasive and have been hypothesized to work by thermally stimulating collagen remodeling and heating sebaceous glands to diminish acne scarring and reduce gland size.

A new bipolar RF device using Functional Aspiration Controlled Electrothermal Stimulation (FACES) technology has been introduced for the treatment of wrinkles and skin laxity.11 FACES combines RF energy with light suction. The heat generated by passing RF energy through the skin shrinks dermal collagen and promotes the formation of new collagen.12 The vacuum suction element confines the heating effect between two RF treatment
Figure 1. A 21-year-old man (skin type III) with acne scars of the left cheek before treatment (left photograph) and after five of six treatments (right photograph) with the bipolar radiofrequency with vacuum device. Treatments consisted of two passes with radiofrequency energy levels at 2 to 4 joules, vacuum pressures at 2 to 3 inches of mercury, and treatment durations at 1.5 to 2.5 seconds. Erythema of severity 1 to 2 (1 = trace, 2 = moderate, 3 = marked, 4 = severe) was present within 30 minutes after each treatment and resolved without intervention. The patient reported no discomfort in five of the six sessions. After five treatments, investigator-assessed improvement was estimated at 25% to 49% and patient-assessed improvement was 50% to 74%. The patient was "very satisfied" with the treatment. The patient had acne since 2006.
 
 
Courtesy of Michael H. Gold, MD
 

electrodes for greater specificity. The treatment head is connected to a vacuum pump that draws the skin between two parallel sets of electrodes located in the tip. High frequency electrical (RF) current is passed through the skin. A flat surface

delivers current more efficiently, so suctioninduced skin deformation provides an effective contact. As such, the FACES treatment modality depends somewhat on the thickness and coarseness of the skin in the target area. This mechanism induces mechanical stress on fibroblasts, leading to collagenesis and possibly a more dramatic improvement of the acne scar.

This device and has been cleared for marketing by the FDA and is intended for use in the non-invasive treatment of wrinkles and rhytides. This study evaluates the use of this bipolar RF device with vacuum for the noninvasive, non-ablative treatment of facial acne scars.

METHODS

Fourteen of the 20 expected subjects (11 women, aged 37.1 ± 10.1 years, skin types II-VI) seeking treatment for mature acne scarring of the face were recruited for the study. Exclusion criteria included pregnancy; recent superficial or deep facial treatments (i.e. peels, lasers, fillers); use of aminolevulinic acid HCl or isotretinoin (oral or topical) on or around the treated area; or prior facial treatment (i.e. chemical peel, dermabrasion) within three months of enrollment; prior use of botulinum toxin, collagen, fat injections or other similar augmentations; skin treatment with laser or other devices on areas to be treated within 6 months of study enrollment or during the course of the study; prior resurfacing procedures in the periorbital area within one year of enrollment; use of an unapproved skin care regimen or a recent change in skin-care regimen; exposure to sunlight or tanning beds; presence of serious skin conditions; and the presence of any other condition that could make treatment unsafe during the study.
 

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