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


This study was IRB approved and informed consent was obtained from all subjects prior to this investigation.

Each treatment area was cleaned using alcohol-free agents to ensure removal of perfumes, cosmetics, or lotions. A fresh disposable treatment tip was used for each patient, with conductive lotion applied on the treatment area immediately before treatment. Optimal parameters for the device were determined using a maximum of ten test spots, with the preferred combination dose resulting in mild to moderate erythema and minimal pain. Treatment parameters were the following: 2 passes, RF energy, 2-4 joules; and treatment duration, 1.5-3.5 seconds. Areas received six treatments at 1-week intervals with follow-up visits to be conducted at 30 and 60 days after the final treatment. Frozen gauze pads or cold ice packs were offered to help cool the treated area after treatment. No anesthesia was required.

Photographs were taken prior to the first, fourth, and sixth treatments for comparative evaluation purposes.

Subjects were informed that transient purpura, posttreatment erythema, edema and/or some discomfort of the treated areas should not be a cause for concern and that make-up can generally be applied immediately after treatment. During the investigation, subjects were advised to use broad spectrum sunscreen of no less than 30 SPF on a daily basis. They also agreed to regularly cleanse their skin gently with tepid water, and hydrate the skin with an approved moisturizer.

Complications and adverse events were monitored and documented.

Results

Improvement and Satisfaction: Improvement and satisfaction with treatment are summarized in Table 1.

Before the fourth treatment, improvement was noticeable in 10 of 14 subjects as judged by both investigator and subjects. Twelve subjects were at least slightly satisfied with the treatment. Before the sixth treatment, improvement was equal to or stronger than before the fourth treatment in 10 subjects as judged by the investigator, subjects, or both. Four subjects were very satisfied or extremely satisfied with the treatment and 1 subject was not

Figure 2. A 37-year-old woman (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 3 joules, vacuum pressures at 2 to 3 inches of mercury, and treatment durations at 3.0 to 3.5 seconds. Erythema of severity 1 (1 = trace, 2 = moderate, 3 = marked, 4 = severe) was present within 30 minutes after most sessions and resolved without intervention. The patient reported slight discomfort in most sessions. After five treatments, investigator-assessed improvement was estimated at 1% to 24% and patient-assessed improvement was 25% to 49%. The patient was "satisfied" with the treatment. The patient had acne since 1984.
 
 
Courtesy of Michael H. Gold, MD
 

satisfied. At the 30-day follow-up, improvement was equal to or stronger than before the sixth treatment as judged by the investigator, subjects or both. At the 60-day follow-up, 3 of 4 subjects were very satisfied with the treatment and improvement was equal to or stronger in all three subjects. Clinical examples are shown in Figures 1 and 2.

Discomfort During Treatment: The median discomfort level during treatment was 1.5 (slight discomfort). The maximum discomfort level of 3 (moderate) occurred only on 5 occasions. No subjects discontinued treatment due to discomfort.

Adverse Effects: Erythema was observed within 30 minutes after treatment in most subjects. The maximum severity was 3.0, which occurred on only one patient. Severity of erythema was generally higher in later treatments. Edema, purpura, or other adverse effects were not observed.

Conclusion

This bipolar RF device with vacuum appears to be a safe and effective method for reducing mild to moderate facial acne scars.

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This study was sponsored by Lumenis, Inc., Santa Clara, CA.