Clinical papers

This paper reports the clinical experience of a multi-center, multiple physician trial with a novel fractional radio-frequency ablative skin resurfacing and rejuvenation device (Fractora, Invasix, Israel) deployed on both Caucasian skin types I – III and Asian skin type IV. Histological study demonstrated deep ablation and collagen restructuring in the papillary and reticular dermis. The Fractora device combines the more “cone shaped” ablation seen with CO2 and Erbium lasers with a deep non-ablative heating pattern, seen with other bipolar RF fractional needle resurfacing devices. Ablation, coagulation zones and healing dynamics are analyzed for different energy settings. Two different treatment protocols are suggested: one for light skin and then one for darker skin with a higher risk of post-inflammatory hyper-pigmentation. Treatment results show improvement in skin texture, pores, wrinkles and skin dyschromia.

Carbon Dioxide laser skin resurfacing (LSR) gained great popularity in the 1990’s because of impressive results seen with skin tightening, wrinkle reduction, improving skin texture and tone after a single treatment session. [1,2] One of the unique features of CO2 laser resurfacing is that it creates almost equal ablation, coagulation and residual sub-necrotic 50-100 micron thermal zones in the skin. [3] The main disadvantages of the procedure were relatively long downtimes with surface discharge followed by prolonged erythema and then long-term risks of hypopigmentation resulting from a poor reservoir of epidermal cells and melanocytes after deep skin ablation.

One of the significant advances in laser skin rejuvenation was the introduction of ablative fractional skin resurfacing [4-6], where small areas of skin, with depths in the range of 100-800 microns were treated with in a fractional fashion, leaving a proportion of the skin intact around the ablative thermal column, keeping this undamaged skin around for fast skin healing after the fractional ablative laser treatment. Over several years and multiple different lasers and wavelengths, the majority of laser manufactures have focused on Fractional CO2 resurfacing [7-8], either as a single aggressive treatment or in several more mild sessions, providing dramatic improvement in skin dyschromia, texture, wrinkles and acne scars, with relatively short downtime and a low rate of side effects that can be minimized by correct patient selection.

An alternative ablative technology is radio-frequency (RF) fractional skin resurfacing [8], which in published studies promotes more superficial ablation and is more focused on non-coagulative dermal residual heat. This relatively comfortable treatment demonstrates some level of improvement over a multiple treatment program. We believe that RF technology need not be limited by this superficial dermal heating.

The current study demonstrates the results with a new fractional RF ablative rejuvenation technology providing a complete single treatment solution for aging patients.

Fractora™ RF fractional rejuvenation by Invasix Ltd. (Yokneam, Israel) improves the appearance of aging skin while offering less downtime than previous technologies. According to the company, the Fractora achieves results that would normally require up to four different technologies. Benefits include stimulating collagen production, a smoother appearance of skin texture, evening of pigmented lesions and an improvement in fine lines and wrinkles.

For F. Richard Noodleman, M.D., a board certified dermatologist in Campbell, Calif. (in the Silicon Valley), Fractora is “a new and very popular technology.” In his practice Dr. Noodleman and his staff perform about 75 procedures a month with this machine. “Our Invasix device is being utilized all day every day,” he stated.

When radiofrequency (RF) fractional skin resurfacing meets thermal-based RF collagen remodeling in a single session, the result is a completely new facial treatment called FracTotal by Invasix (Yokneam, Israel). By performing Fractora Firm skin tightening and Fractora skin resurfacing in succession, aesthetic physicians are able to successfully address deterioration and descent – two of the three “D’s” (deterioration, descent and deflation) in the aging face.

Facial aging is a combination of intrinsic, hereditary and extrinsic forces. Extrinsic factors, including UV light exposure, smoking and diet, combined with the heretics and intrinsic aging factors results in facial deflation (loss of fat), descent (laxity) and deterioration (aging skin). Skin aging and deterioration is characterized by reduced and abnormal collagen, elastin and ground substances, together with discoloration, both in increased melanin based lesions and vascular proliferation. Anti-aging physicians have generally had to combine various lasers, intense pulsed light (IPL), infrared (IR) and radio-frequency (RF) energy systems to treat the combination of these aging dermal and epidermal elements. (Table 1). Fractional and non-fractional radio-frequency energy systems have become popular options in the treatment of skin laxity and wrinkles, but have not been generally effective in treating vascular and melanin based dyschromia of the aging skin. This paper reports on the comprehensive anti-aging effects of a novel new fractional radio-frequency device, the Fractora (Invasix, Yokneam, Israel).

An analysis of the technologies listed in Table 1 reveals the following therapeutic interventions are required for the wide array of aging effects we see in the skin:

• Pigmented malformation treatment requires superficial ablation or coagulation
• Vascular lesion treatment requires coagulation of blood vessels in papillary and reticular dermis
• Wrinkle treatment requires ablative and/or sub-necrotic heating of the reticular dermis
• Skin laxity improvement requires deeper heating of the reticular dermis and dermal-fat junction

The ideal situation for the aesthetic professional would be to have one technology with the tunable ability to address all the clinical manifestations of aging skin. The principal difference between the ablative and non-ablative RF in the novel device used in the current study, when compared with light based deep fractional ablation is that the action of RF is not limited by the ablation crater and adjacent tissue based upon a chromophore, but rather, RF current flows through the ablative lesion and the entire reticular dermis, creating the potential for additional anti-aging effects [10].

This current study describes the results of the clinical evaluation of a novel fractional radio-frequency ablative and semi-ablative treatment used to treat the multiple aging pathologies of the skin.