Clinical Evaluation of Safety and Efficacy of Fractional Radiofrequency Facial Treatment of Skin Type VI Patients
November 2018 | Volume 17 | Issue 11 | Original Article | 1169 | Copyright © 2018
Eliot F. Battle Jr. MD and Sally Battle CNMT
Cultura Dermatology & Plastic Surgery, Washington, DC
INTRODUCTION: It has been well established that patients with darker skin types (Fitzpatrick skin types IV-VI) have an increased incidence of thermal induced side effects from laser and radio frequency (RF) treatments. Complications include a higher risk of post-inflammatory hyperpigmentation, hypopigmentation, and scarring, leading to unsatisfactory clinical outcomes. Fractional technologies improve the safety when treating patients with skin of color by treating only fractions of the skin while leaving a healing reservoir of untreated skin that improves the healing process. Fractional RF tips with coated pins may offer a more advantageous safety profile, particularly in the skin-of-color population (Fitzpatrick skin types IV-VI) by increasing the protection of the epidermal layer by minimizing epidermal heating The current study was intended to evaluate the safety and efficacy of fractional RF technology for the treatment of patients with Fitzpatrick skin type VI. METHODS: 35 subjects with skin type VI received 3 sessions of facial treatments, 4 weeks apart using a fractional RF device with 24 pin coated tip. The treatment's safety and efficacy were evaluated at 2 follow-up visits, 6 and 12 weeks after the last treatment. RESULTS: Skin characteristics evaluations, including Fitzpatrick Wrinkles Classification, acne scars, and overall facial appearance demonstrated improvement in follow-up visits comparing to baseline. No significant unexpected adverse events were detected. CONCLUSION: The current study proves the safety and efficacy of the fractional RF treatment modality with coated pins tips for skin rejuvenation treatments resulting in improved wrinkles, acne scars, and overall skin appearance, in patients with skin type VI. J Drugs Dermatol. 2018;17(11):1169-1172.
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Fractional skin resurfacing with non-ablative near-infrared laser wavelengths were introduced more than 10 years ago, in an effort to deliver high non-ablative columns of energy into the dermis. This treatment resulted in micro-coagulation zones formation and in collagen remodeling but left a significant portion of the adjacent skin untreated to act as a healing reservoir of cells for the non-ablative micro-coagulation zones.1 In order to produce more significant results, ablative technologies like CO2 used a fractional approach to create ablation columns with depth up to 2mm. These fractional ablative lasers provided the outcome advantages of ablative technique, but with improved recovery and minor risk of side effects. Fractional CO2 and other fractional ablative wavelengths have shown excellent improvement in wrinkles, photo-aging, and acne scars.2-4Although these modalities can be effective, they may be associated with prolonged recovery and adverse effects. Complications, such as post inflammatory hyperpigmentation (PIH), hypopigmentation, and scarring are at higher risk of occurring in patients with Fitzpatrick skin types IV-VI.5 These potential adverse effects can all lead to decreased use of resurfacing procedures when treating patients with skin-of-color.More recently, fractional RF technology was introduced for skin resurfacing.6 It creates a low density fractional epidermal and superficial dermal coagulation under the conductive pins and delivers RF travelling through the reticular dermis, combining a low density ablative effect in the epidermis with sub-necrotic heating in deeper layers of the skin. This fractional RF approach, with relatively low impact epidermal-junctional effect and deep dermal effect, has demonstrated improvement in lines, acne scars, and pigmentation after multiple treatment sessions.6,7 The technology sometimes compromises with treatment efficiency in comparison to deep ablative fractional lasers, but due to deeper collagen remodeling, delivers consistent and safe results aftera number of non-aggressive treatment sessions. This technology was demonstrated to be particularly good for tissue tightening and acne scar treatment in Caucasian as well as Asian skin.7The objective of this study is to demonstrate the safety and efficacy of the 24 pins coated tip for facial treatments of patients with skin type VI.
The goal of this single center clinical study was to evaluate safety and efficacy of a fractional RF applicator (Fractora, In- Mode Ltd., Israel) for the treatment of facial wrinkles, fine lines, acne scars, and laxity on skin type VI.Thirty-five subjects (25 females and 10 males) between the ages