Clinical Evaluation of Safety and Efficacy of Fractional Radiofrequency Facial Treatment of Skin Type VI Patients

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