Narurkar Vic A, Alster Tina S, Bernstein Eric F, Lin Tina J, Loncaric Anya
J Drugs Dermatol. 2018 Jan 1;17(1):41-46.
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.
.分次光热解(FP)是治疗光损伤皮肤的一种常用方法,它弥补了剥脱性皮肤磨削术和非剥脱性真皮重塑的不足。以往研究表明,使用1550nm波长的FP可改善深层真皮结构中与光损伤皮肤相关的超微结构变化和临床效果,而使用1927nm波长的治疗则在浅表真皮显示出临床效果。两种波长均可在皮肤中产生精确的微观治疗区(MTZ)。联合使用这两种波长可能会优化用于光损伤皮肤真皮和表皮凝固的非剥脱性分次换肤的效果。
评估1550/1927激光系统(飞梭双波长,索塔公司)联合使用1550nm和1927nm波长治疗面部和非面部光损伤的安全性和有效性。
对35例具有临床可识别光损伤的受试者(Fitzpatrick皮肤分型I-IV型)进行前瞻性、多中心上市后研究。每次治疗均使用1550nm和1927nm波长。在进行一系列最多4次治疗后的1周、1个月和3个月,由研究者对受累区域进行评估。使用4分制量表(0=无,3=明显)评估不良事件(AE)的严重程度。评估内容包括红斑、水肿、角化过度、色素沉着过度和色素沉着不足、瘢痕形成、瘙痒、干燥和脱屑。使用相同量表评估基线时光老化、细纹和粗皱纹、斑驳色素沉着、面色发黄和触觉粗糙的严重程度。在所有随访中,研究者和受试者根据5分四分位改善量表评估光损伤和色素沉着的总体外观(0=无改善,4=非常显著改善[76%-100%])。
在所有研究访视中均有积极的治疗效果,在最后一次治疗后3个月观察到中度改善(严重程度平均降低21%-43%)。其他受益区域严重程度的最大降低出现在随访3个月时,细纹和触觉粗糙的严重程度分别降低了21%和30%。未报告AE或严重AE。治疗期间的疼痛感觉可耐受。预期的中度红斑(平均评分1.6±0.5)和轻度水肿(平均评分0.8±0.7)是短暂的,在7-10天内消退。在随访1周时报告了预期的短暂轻度干燥(52%的受试者)和脱屑(30%)。未发生角化过度、瘢痕形成或瘙痒。
联合使用1550/1927激光系统的两种波长进行治疗耐受性良好,预期副作用有限且短暂,未出现严重AE。在进行一系列最多3次治疗后,光损伤和色素沉着外观的临床疗效最佳。
《皮肤药物学杂志》2018年;17(1):41-46。