Unit of Dermatology, Department of Surgery and Translational Medicine, P. Palagi Hospital, University of Florence, Florence, Italy -
Unit of Dermatology, Department of Surgery and Translational Medicine, P. Palagi Hospital, University of Florence, Florence, Italy.
G Ital Dermatol Venereol. 2019 Dec;154(6):632-637. doi: 10.23736/S0392-0488.17.05603-6. Epub 2017 Apr 11.
Reactive oxygen species have a major role in the UV-induced short- and long-term damage, thus the exogenous supplementation of antioxidant molecules may allow better skin protection. Despite glutathione has pivotal properties in the complex cytoplasmic antioxidant system, its supplementation is hampered by limited transmembrane absorption. Modification of glutathione pharmacokinetic properties via acetylation with long-chain polyunsaturated fatty acid may improve its passage through phospholipidic membranes.
This was a single center randomized double-blinded clinical trial, versus placebo, cross-sectional pairwise at time 0. The participants were 10 healthy volunteers with skin phototypes II or III and age ≥18 years interested in performing minimal erythema dose (MED) evaluation performed by photoallergology unit of Division of Dermatology at P. Palagi Hospital, in Florence. Each volunteer underwent UVB phototesting, treating four different areas with increasing UVB doses in four different conditions. One arm was treated as standard procedure (naïve arm), one applying linolenic-glutathione conjugate (Lin-GSH) cream 2% before irradiation (pre-Lin-GSH arm), one with placebo (placebo arm) and one applying Lin-GSH cream 2% (SoloSale Srl, Florence, Italy) after irradiation (post-Lin-GSH arm). The main endpoint was to evaluate efficacy of Lin-GSH cream 2% before UVB irradiation compared with placebo. A secondary endpoint was the evaluation of the same cream applied after irradiation compared to no treatment. Another secondary objective is the evaluation of safety in both conditions. Mean MED was evaluated at distinct conditions. Safety was evaluated reporting all grade 3-4 adverse events up to 30 days after treatment. All volunteers were treated in all four experimental conditions. The pre-Lin-GSH and placebo arms were applied in a double-blind condition for each volunteer. Neither the volunteer nor the investigator executing MED evaluation knew which arm was given Lin-GSH and which one placebo.
Ten volunteers among 12 recruited for the study were correctly randomized and completed all study evaluations. Recruitment went from April 1st, 2016 to May 1st, 2016, up to adequate population number. Mean MED in pre-Lin-GSH arm was superior to mean MED in placebo arm (135±5.53 mJ/cm2 vs. 105±7.64 mJ/cm2, P=0.0003). No difference was observed among mean MED in post-Lin-GSH and naïve arms. No grade 3-4 adverse events were reported.
Lin-GSH 2% cream seems a safe and effective in producing a significant increase in MED compared with placebo thanks to its antioxidant properties.
活性氧在 UV 诱导的短期和长期损伤中起主要作用，因此外源性补充抗氧化分子可能会提供更好的皮肤保护。尽管谷胱甘肽在复杂的细胞质抗氧化系统中具有关键特性，但由于其跨膜吸收有限，其补充受到阻碍。通过用长链多不饱和脂肪酸乙酰化修饰谷胱甘肽的药代动力学特性，可以改善其通过磷脂膜的传递。
这是一项单中心随机双盲临床试验，与安慰剂对照，在 0 时间点进行横截面配对。参与者为 10 名健康志愿者，皮肤光型为 II 或 III 型，年龄≥18 岁，有兴趣进行最小红斑剂量 (MED) 评估，由佛罗伦萨 P. Palagi 医院皮肤科分部的光变态反应单位进行。每个志愿者都接受了 UVB 光测试，在四个不同条件下用递增的 UVB 剂量处理四个不同的区域。一个手臂按标准程序处理（对照臂），一个手臂在照射前应用亚麻酸-谷胱甘肽缀合物 (Lin-GSH) 乳膏 2%（预 Lin-GSH 臂），一个手臂应用安慰剂（安慰剂臂），一个手臂在照射后应用 Lin-GSH 乳膏 2%（SoloSale Srl，佛罗伦萨，意大利）（后 Lin-GSH 臂）。主要终点是评估 Lin-GSH 乳膏 2%在 UVB 照射前的疗效与安慰剂相比。次要终点是评估照射后应用同一种乳膏与无治疗相比的效果。另一个次要目标是评估两种情况下的安全性。在不同条件下评估平均 MED。在治疗后 30 天内报告所有 3-4 级不良事件以评估安全性。所有志愿者均在所有四个实验条件下接受治疗。预 Lin-GSH 和安慰剂手臂在每个志愿者中均以双盲方式应用。志愿者和执行 MED 评估的研究员都不知道哪个手臂给予了 Lin-GSH，哪个手臂给予了安慰剂。
在研究中招募的 12 名志愿者中有 10 名被正确随机分组并完成了所有研究评估。招募工作于 2016 年 4 月 1 日至 5 月 1 日进行，直至达到足够的人口数量。预 Lin-GSH 手臂的平均 MED 明显优于安慰剂手臂（135±5.53 mJ/cm2 与 105±7.64 mJ/cm2，P=0.0003）。Lin-GSH 后臂和未处理臂之间的平均 MED 无差异。未报告 3-4 级不良事件。
Lin-GSH 2%乳膏似乎是一种安全有效的制剂，由于其抗氧化特性，可显著提高 MED 与安慰剂相比。
