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. 128 DISCUSSION This randomized controlled trial evaluated the efficacy and tolerability of EPI-assisted intralesional bleomycin treatment in patients with severe keloids. We found a significant decrease of 20% in keloid volume after three consecutive bleomycin EPI treatments whereas placebo-treated lesions remained unchanged. Importantly, this decrease was paralleled by a substantial improvement of the POSAS patient and – observer scale of 28% and 26%, respectively after bleomycin treatment. Contrary to our hypothesis, the effect of bleomycin does not occur through permanent changes in microcirculation. Importantly, no severe adverse events occurred. Notably, in the majority of patients mild hyperpigmentation was observed in the bleomycin treated keloids. This phenomenon was previously observed in other intralesional bleomycin studies, but was not regarded as bothersome by most patients.24 In line with our previous findings, 85% of the patients preferred treatment with the jet injector over conventional needle injections, which supports the use of needle-free injector devices as patient-friendly alternative delivery method in this patient group.21,22,25 A previous study of Rijsbergen et al., showed that the 3D imaging technique that was used in our study is an accurate and reliable method for the clinical visualization of HPVinduced skin lesions.26 No previous trials have been published that used highly sensitive objective 3D measurements in conjunction with patient reported outcomes to assess the clinical effects of intralesional bleomycin treatment in patients with keloids. Khan et al. compared six treatments of intralesional bleomycin vs. TCA using conventional needle injections, and found a significant improvement in mean combined POSAS score (sum of patient- and observer score) of 72% vs. 67%, respectively.27 When intralesional bleomycin was compared with intralesional 5-fluorouracil with or without TCA, mean improvements of 73%, 54% and 55% on the Vancouver Scar Scale were observed after two to six treatments.28 It is noteworthy to mention that, in the majority of keloid studies, a dosage of 0.375 U intralesional bleomycin was injected every cm2 using conventional needle injectors or spring loaded jet injectors.15,27-29 Despite the good efficacy achieved in these studies, bleomycin treatment led to a high rate of treatment discontinuations and mild to
RkJQdWJsaXNoZXIy MTk4NDMw