Intralesional bleomycin treatment of keloids using an electronic pneumatic jet injector: a double-blind randomized, placebo-controlled trial with split-lesion design - BLEO JET

Erasmus MC0 个研究点目标入组 15 人开始时间: 2021年3月10日最近更新: 2021年6月7日

适应症

试验速览

暂无简介。

•1.Subject has provided written informed consent;
•2.Subject is = 18 years of age at time of screening;
•3.Subject has at least one keloid scar of = 4 cm in length, or two separate keloids with a length of =2cm, with a minimum > 1.0 cm apart in the same anatomical region.
•4.Subject is willing to fill in questionnaires and take photos using an e-diary application on a smartphone.
•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 15
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Known hypersensitivity to any component of the test materials;
•2.Pregnant or breast-feeding women (beta-HCG test prior to treatment);
•3.Previous bleomycin treatment of the keloid within the last 12 weeks prior to screening.
•4.Non-response to previous bleomycin treatments of the keloid.
•5.Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.

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