Impact of thermo-mechanical intervention on Protoporphyrin IX accumulation and biodistribution in normal skin following topical 5-aminolevulinic acid at high and low vehicle viscosity

Merete Hædersdal0 个研究点目标入组 16 人开始时间: 2019年1月29日最近更新: 2019年12月10日

试验速览

暂无简介。

•Healthy participants above 18 years of age
•Fitzpatrick skin type I-III and normal skin on the upper back
•Fertile women with negative U-hCG and with use of safe anticontraceptive during the entire study period e.g. oral hormonal contraceptives, intrauterine devices, subdermal implantation or hormonal vaginal ring
•Provided informed written consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 16
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•No previous PDT or laser treatment within the past 6 months in the study areas
•Pregnant or lactating women
•Participants with known allergy to 5-ALA, lidocaine or any excipients to components in the vehicles
•Considered unable to follow the study protocol

发起方

Merete Hædersdal