Efficacy of D-pigment dermocosmetic lightening product for solar lentigo lesions of the hand: A randomized controlled trial

Solar lentigo, benign lesions which mostly appear on chronically, sun-exposed surfaces, are associated with ageing. Patients are increasingly requesting a more uniform skin texture, especially for hands. Treatment options include dermoabrasion, intense pulsed light, cryotherapy, peelings, and laser therapy. Topical compounds can be employed, in alternative or associated with dermatologic procedures. The current study was designed to evaluate solar lentigo hyperpigmentation, skin architecture and clinician and patient assessments comparing a dermocosmetic lightening product (active) with a moisturizing product (control) according to clinical, digital and subjective analyses in 72 lesions over 12-month follow up period. Statistically significant differences were observed between the lesions treated with the active compared to the control in terms of papillary brightness (p = 0.03) and contrast (p = 0.03), and in the limitation of dermal-epidermal junction destructuring (p = 0.03) according to dermal-epidermal junction destructuring score at Reflectance Confocal Microscopy. Luminance (p = 0.04) and redness (p = 0.03) were improved at color analysis, and physician and patient evaluations favored the active in efficacy and patient satisfaction investigations. The dermocosmetic lightening product utilized in the current study proved to be more effective, according to clinical, digital and subjective analyses in reducing lesion hyperpigmentation, stabilizing the lesion skin architecture and increasing patient satisfaction compared to the control in a cohort of 36 subjects, over a 12-month period. Beside demonstrating the efficacy of this topical lightening product, we propose a “destructuring score”, which improves the robustness of solar lentigo’s evaluation, and can be used in future studies to standardize the quantitative comparisons of different treatment options.

日光性雀斑样痣（solar lentigo）是一种多出现于慢性日晒部位的良性皮损，与衰老过程密切相关。患者愈发渴望获得均匀一致的皮肤质地，手部皮损的相关诉求尤为突出。可供选择的治疗手段包括皮肤磨削术、强脉冲光、冷冻治疗、化学剥脱术与激光治疗；外用制剂也可作为单一治疗方案，或联合皮肤诊疗操作使用。
本研究旨在对比一款医用护肤美白产品（活性组）与保湿产品（对照组）对日光性雀斑样痣色素沉着、皮肤结构的改善效果，采用临床、数字成像与主观评估手段，对72处皮损开展为期12个月的随访分析。
反射式共聚焦显微镜（Reflectance Confocal Microscopy）检测显示，活性组皮损的乳头层亮度（p=0.03）、对比度（p=0.03）均显著优于对照组，且可有效抑制表皮真皮连接处的结构破坏（p=0.03）。色度分析结果表明，活性组可提升皮损亮度（p=0.04）并改善红斑表现（p=0.03）；在有效性与患者满意度评估中，医师与患者均认为活性组更具优势。
本研究队列共纳入36名受试者，经12个月随访后，综合临床、数字成像与主观评估结果可见，相较于对照组，本次研究使用的医用护肤美白产品可更有效地减轻皮损色素沉着、稳定皮损处皮肤结构，并提升患者满意度。本研究除证实该外用美白产品的临床疗效外，还提出了"结构破坏评分"，该评分可提升日光性雀斑样痣评估的可靠性，未来可用于标准化不同治疗方案的定量对比分析。