5. Needle-free electronically-controlled jet injector treatment with bleomycin is efficacious and well-tolerated in patients with severe keloids: results of a randomized, double-blind, placebo-controlled trial. 119 5. METHODS Study design BLEOJET (NCT04582305) is a double-blind, randomized, placebo-controlled trial, with split-lesion design to evaluate the efficacy and tolerability of bleomycin compared to placebo, in keloids using an EPI. The Medical Ethics Review Committee (METC) of Erasmus MC in Rotterdam approved the study in May 2021 (NL74548.078.20). The study was conducted between March 2022 and December 2022 at the Dermatology department of Erasmus University Medical Center, Rotterdam, the Netherlands. Patients Inclusion criteria were age ≥ 18 years, at least one keloid of ≥ 4 cm in length, or two separate keloids of ≥ 2 cm with a minimum > 1 cm apart in the same anatomical regional, and willingness to fill in questionnaires and take photos using an e-diary application. A maximum of two large (≥ 4 cm) keloids were included to be treated in the trial. Exclusion criteria were hypersensitivity to any component of the test materials, pregnancy or breast-feeding women, previous bleomycin treatment of the keloid within the last 12 weeks prior to screening, non-response to previous bleomycin treatments of the keloid, and any medical or psychiatric condition which would preclude the participant from adhering to the protocol or completing the study per protocol. Randomization The participants, treating physicians, and other investigators were blinded for the allocation of treatment. One larger keloid (≥ 4 cm) that was divided into two comparable halves, or two comparable smaller keloids (< 4 cm) were included. Each lesion half was randomly assigned to three consecutive treatments with bleomycin, or three consecutive placebo (physiological saline) treatments. Allocation and sequence were randomized by a validated computer system (SAS version 9.4 M6, SAS Institute, Cary, NC, USA) in blocks of four by a study-independent statistician. The randomization list was administrated and stored in a locked office at our hospital pharmacy. Blinding was concealed by an
RkJQdWJsaXNoZXIy MTk4NDMw