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. 126 Microcirculation Cutaneous microcirculation of the lesions was quantified using LSCI. No statistically significant differences in cutaneous microcirculation were observed with bleomycin versus placebo at follow-up (Figure 2b; Table 2). Residue formation The extent of drug spillage was evaluated by collecting the residual fluid on the skin surface. In total, 50.0% (±11.8%) of the injected volume with bleomycin and 43.6% (±8.6%) with physiological saline of residual fluid was observed. Safety and tolerability Overall, intralesional bleomycin treatment with the EPI was well tolerated (Table S4). No severe adverse events or treatment discontinuations occurred during the study. However, two out of fourteen patients (14%) developed transient superficial necrosis at the injection site, which recovered in approximately four weeks. Furthermore, in the bleomycin treated lesions temporary bruising occurred in two patients (14%), and mild hyperpigmentation was observed in most patients (71.4%%, n=10) at four-weeks followup. No infection or ulceration was observed. All adverse events were mild and transient.
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