Tolerabililty of laser-assisted cisplatin+5-fluorouracil? an exploratory proof of concept study of topical combination chemotherapy for basal cell carcinoma

Merete Hædersdal0 个研究点目标入组 24 人开始时间: 2018年1月25日最近更新: 2020年5月11日

适应症

试验速览

暂无简介。

•Subjects who meet all of the following criteria are eligible to participate in this study:
•1.Histologically-verified, previously untreated superficial or nodular BCCs on the scalp, face, extremities or trunk
•2.>18 years of age at baseline
•3.Legally competent, able to give verbal and written consent
•4.Subject in good general health, is willing to participate and able to give informed consent, and can comply with protocol requirements.
•5.Fitzpatrick skin phototype I-III
•6.Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.
•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 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•Subjects meeting any of the following criteria are not eligible to participate in this study:
•1.High-risk BCC:
•i.Tumors in the following anatomical locations: midface, orbital, ears
•ii.Size: >20 mm in facial/scalp areas or > 50mm in non-facial/non-scalp areas
•iii.Subtype: Mopheraform or micronodular
•iv.History: Gorlin syndrome or immunesuppression
•2.Previous treatment of the BCC lesion
•3.Known allergy to cisplatin or Efudix®
•4.Other skin diseases in the area of interest
•5.Tattoo in the treatment area which may interfere with or confound evaluation of the study
•6.History of keloids which is deemed clinically relevant in the opinion of the investigator
•7.Fitzpatrick skin phototype IV-VI
•8.Lactating or pregnant women

发起方

Merete Hædersdal