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. 125 5. Figure 1 Clinical pictures (1a) and 3D-images (1b) of two keloid lesions which were treated with respectively placebo and bleomycin. A reduction of 46% in volume was detected in the intervention site at follow-up compared to baseline, while the lesion that received placebo did not change. Patient-reported pain and treatment satisfaction The patient-reported NRS pain score during EPI treatment was similar for both treatments (bleomycin: LSM 5.4; CI 4.5, 6.3; placebo LSM 5.6; CI 4.5, 6.3; p=0.54). The overall satisfaction of the treatment resulted most frequently in ‘satisfied’ (69.2%; n=13; Table S3). Moreover, the majority of patients (84.6%; n=13) preferred EPI over conventional needle injections. All patients (100%; n=13) would recommend EPI treatment with intralesional bleomycin to others. Week 0 Week 4 Week 8 Week 12 Placebo Bleomycin 5 mm 5 mm 5 mm 5 mm 5 mm 5 mm 5 mm 5 mm
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