Clinical Evaluation of the Safety and Efficacy of a Novel Superficial and Deep Carbon Dioxide Fractional System in the Treatment of Patients With Skin of Color
November 2012 | Volume 11 | Issue 11 | Original Article | 1331 | Copyright © 2012
Fractional carbon dioxide (CO2) laser treatments have become a standard for treating a myriad of skin concerns. One of the biggest
challenges facing us in this regard is treating the vast number of patients with skin of color who we encounter regularly in our practices.
A novel superficial and deep CO2 ablative fractional device with both components coming from a single handpiece has been
developed and is now being evaluated for patients with skin of color. In the 5 patients studied, side effects were not apparent and
no postinflammatory hyperpigmentation was identified. This initial report suggests further evaluation is important to enhance our
ablative fractional therapies.
J Drugs Dermatol. 2012;11(11):1331-1335.
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Fractional laser therapy has become one of the mainstays of laser therapy around the world to treat a myriad of skin care concerns. Clinical evidence-based medicine has shown great success for these devices in improving the signs of photodamage, including fine lines and wrinkles, pigmentary dyschromias, and even skin laxity. In addition, fractional lasers have been shown to improve scars, whether from acne or trauma.1,2
When determining the most effective treatment, many clinicians realize that in order to achieve the desired clinical effect, a fraction laser that can generate "damage" that is superficial in nature or that has the ability for deeper penetration will allow customization for the individual patient and the specific target area. This challenge has prompted the development of the Acu- Pulse MultiMode carbon dioxide (CO2) fractional laser (Lumenis Ltd, Yokneam, Israel).
In a recently published clinical manuscript, Gold and Biron3 enrolled 15 subjects with photodamaged skin in an institutional review board-approved clinical research study to evaluate the improvement achieved in fine lines and wrinkles, as well as the overall skin texture in the treated individuals following a single treatment with a combination deep and superficial ablative fractional device. These subjects received a deep AcuPulse treatment in the perioral and periorbital regions followed by a full-face superficial treatment. The AcuPulse treatment parameters used in this initial clinical trial were as follows: for the deep fractional component, energy was 5 to 20 mJ in a superpulsed mode, and a density of 5% to 15%; for the superficial component, energy of 50 to 170 mJ was used in a continuous mode, and at a density of 40% to 60%. Each patient was treated once and then followed up with at 7 days, 30 days, and 90 days following the therapy.
Investigators rated the effectiveness, as assessed by improvement of wrinkles, pigmentation, and overall skin, as good to very good in 50% of the subjects. The average wrinkle score and pigment score mirrored this effectiveness, with reductions from 4.3 and 4 to 2.8 and 2.7, respectively, at the end of the study. These reductions were statistically significant as compared with baseline (P<.01, t test for paired data). Subject assessment and satisfaction confirmed the results as at least 65% of the subjects graded the results as good to very good at the 3-month followup visit, and more than 85% of the subjects were satisfied with the treatment. There was a high correlation (0.79) between the subjects' perception of improvement and satisfaction.
From this initial clinical study, the evaluation to treat skin of color was warranted in 5 individuals in a commercial setting and will be outlined in this report. This report will review the Acu- Pulse device itself and some early clinical experience and will detail new experience utilizing the machine on patients with skin of color. As patients with skin of color are a growing population in the field of dermatology, establishing the safety and efficacy of laser devices is a priority in their care. The purpose of this report is to discuss the safety and efficacy of this new device in a diverse population of patients with skin of color.