Duteil Luc, Queille-Roussel Catherine, Aladren Sonia, Bustos Xavier, Trullas Carles, Granger Corinne, Krutmann Jean, Passeron Thierry
CPCAD, Hôpital l'Archet 2, Nice, France.
Innovation and Development, ISDIN, Barcelona, Spain.
Dermatol Ther (Heidelb). 2022 Jul;12(7):1603-1613. doi: 10.1007/s13555-022-00755-5. Epub 2022 Jun 18.
Polymorphic light eruption (PLE) is the most common idiopathic, acquired photodermatosis. The pathophysiology of PLE is not yet fully understood but seems to involve immunological mechanisms, UVA-induced oxidative stress, and the subsequent elicitation of a cellular stress response affecting keratinocyte gene expression and skin immune function. In the present study, a high broad-spectrum sunscreen medical device (MD), containing a very high protection complex of UVB and UVA filters and ectoin, was investigated for its ability to protect against UVA-induced PLE.
The study was carried out as a monocentric, double-blinded, randomized, untreated controlled design. The test MD was applied (2 mg/cm) on one side of the chest according to a randomization list of 15 patients with a typical history of PLE, and the contralateral area remained untreated. After product application, the test areas were exposed daily to increasing doses of UVA radiation (from 40 to 60 J/cm) until a PLE reaction was detected or for a maximum of five consecutive days. Evaluations of induced PLE included clinical scoring and chromametry for erythema and pigmentation.
Overall, no positive PLE reaction was observed on the side of the chest treated by the test MD, whereas positive PLE reactions were triggered on the untreated side of 13 subjects. Subjective sensations were very rare on the MD-treated side but were numerous and more severe on the untreated side. Chromametry and clinical visual inspection indicated that the skin color was unchanged on the MD-protected side, whereas high increased values of erythema and pigmentation were observed on the untreated chest side.
This MD sunscreen based on a complex of UVA-UVB filters and 1% of ectoin may be effective in preventing UVA-induced PLE. New studies comparing this MD sunscreen versus the same product without ectoin should be conducted.
gov identifier: NCT05320315 (retrospectively registered 09/17/2021).
多形性日光疹（PLE）是最常见的特发性获得性光皮肤病。PLE的病理生理学尚未完全明确，但似乎涉及免疫机制、UVA诱导的氧化应激，以及随后引发的影响角质形成细胞基因表达和皮肤免疫功能的细胞应激反应。在本研究中，对一种含有非常高防护性的UVB和UVA滤光剂以及依克多因的高广谱防晒医疗器械（MD）预防UVA诱导的PLE的能力进行了研究。
本研究采用单中心、双盲、随机、未治疗对照设计。根据一份随机列表，对15例有典型PLE病史的患者，在其一侧胸部涂抹测试MD（2mg/cm），对侧区域不做处理。涂抹产品后，测试区域每天接受递增剂量的UVA辐射（从40至60J/cm），直到检测到PLE反应或最多连续照射五天。对诱导的PLE的评估包括红斑和色素沉着的临床评分及色度测定。
总体而言，在测试MD处理的胸部一侧未观察到阳性PLE反应，而在13名受试者未处理的一侧引发了阳性PLE反应。在MD处理侧主观感觉非常罕见，但在未处理侧则很多且更严重。色度测定和临床目视检查表明，MD防护侧的皮肤颜色未改变，而在未处理的胸部一侧观察到红斑和色素沉着值大幅升高。
这种基于UVA-UVB滤光剂复合物和1%依克多因的MD防晒霜可能对预防UVA诱导的PLE有效。应开展新的研究，将这种MD防晒霜与不含依克多因的相同产品进行比较。
美国国立医学图书馆临床试验注册中心标识符：NCT05320315（2021年9月17日追溯注册）
