Safety and Efficacy of a 1550nm/1927nm Dual Wavelength Laser for the Treatment of Photodamaged Skin
January 2018 | Volume 17 | Issue 1 | Original Article | 41 | Copyright © January 2018
Vic A. Narurkar MD,a Tina S. Alster MD,b Eric F Bernstein MD,c Tina J. Lin PharmD,d and Anya Loncaric MSe
aBay Area Laser Institute, San Francisco, CA bWashington Institute of Dermatologic Laser Surgery, Washington, DC cMain Line Center for Laser Surgery, Ardmore, PA dValeant Pharmaceuticals, North America, LLC, Bridgewater, NJ
Abstract
BACKGROUND: Fractional photothermolysis (FP) is a popular treatment option for photodamaged skin and addresses shortcomings of ablative skin resurfacing and nonablative dermal remodeling. Previous studies have demonstrated that FP using the 1550nm wavelength has led to improvement of ultrastructural changes and clinical effects associated with photodamaged skin in the deeper dermal structures, while treatment with the 1927nm wavelength has shown clinical effects in the superficial dermis. Both wavelengths produce precise microscopic treatment zones (MTZs) in the skin. The two wavelengths used in combination may optimize the delivery of fractional nonablative resurfacing intended for dermal and epidermal coagulation of photodamage skin.
OBJECTIVES: To evaluate the safety and efficacy of a 1550/1927 Laser System (Fraxel Dual, Solta), using both 1550nm and 1927nm wavelengths in combination for treatment of facial and non-facial photodamage.
METHODS: Prospective, multi-center, post-market study in subjects with clinically identifiable photodamage (N=35) (Fitzpatrick skin types I-IV). Both 1550nm and 1927nm wavelengths were used at each treatment visit. Investigator assessment of the affected area(s) occurred at one week, one month and 3 months after a series of up to four treatments. Severity of adverse events (AEs) were assessed using a 4-point scale (where 0=none and 3=marked). Assessments included erythema, edema, hyperkeratosis, hyper- and hypo-pigmentation, scarring, itchiness, dryness, and flaking. Severity of photoaging, fine and coarse wrinkling, mottled hyperpigmentation, sallowness, and tactile roughness at baseline was assessed using the same scale. Investigators and subjects assessed overall appearance of photodamage and pigmentation based on a 5-point quartile improvement scale at all follow-up visits (where 0=no improvement and 4=very significant improvement [76%-100%]).
RESULTS: There was a positive treatment effect at all study visits, with moderate improvement (average reduction in severity of 21%-43%) observed 3-months after final treatment. Greatest reduction in severity of other benefit areas was at the 3-month follow-up visit, with a 21% and 30% decrease in severity in fine wrinkling and tactile roughness. No AEs or serious AEs were reported. Pain sensation during treatment was tolerable. Anticipated moderate erythema (mean score 1.6±0.5) and mild edema (mean score 0.8±0.7) were transient and resolved within 7-10 days. Anticipated and transient mild dryness (52% of subjects) and flaking (30%) were reported at the 1-week follow-up. There were no incidences of hyperkeratosis, scarring, or itchiness.
CONCLUSION: Treatments using both wavelengths associated with the combined 1550/1927 Laser System were well tolerated with limited, transient anticipated side effects and no serious AEs. Clinical efficacy in the appearance of photodamage and pigmentation was greatest following a series of up to 3 treatments.
J Drugs Dermatol. 2018;17(1):41-46.
INTRODUCTION
Long-term exposure to sunlight produces visible signs associated with photodamage and aging, including freckles, sun and age spots, wrinkling, solar elastosis, actinic keratosis, skin cancer, and melasma. Outside of routine skin surveillance which includes sun avoidance and protection, currently recognized modalities for photodamage treatment include hydroquinone (HQ), hyaluronic acid gel, chemical peels, carbon dioxide (CO2) lasers, and fractional photothermolysis (FP).There is increasing demand for effective treatments that result in minimal side effects and downtime for patients.1 While laser treatments, such as ablative CO2 and erbium:yttrium-aluminium-garnet (Er:YAG) lasers, are effective, they are often associated with complications, wound care, and side effects causing extended clinical and social downtime.2 Fractional resurfacing with laser devices of different wavelengths to treat photodamaged skin has become a popular treatment options for photodamaged skin, with a dramatic effect on medical and aesthetic dermatology.3-5FP employs an array of small laser beams to create many microscopic areas of thermal necrosis within the skin called microscopic treatment zones (MTZs) extending between 400
