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. 123 5. RESULTS Demographics Fourteen patients with at least one keloid were included (age range 18–48 years, 9 females; Fitzpatrick skin type I–VI, Table 1 and Table S1). In four patients, two smaller separated keloid lesions were assigned to treatment with bleomycin or placebo. In the remaining ten patients, one large (> 4 cm diameter) keloid was divided in two smaller lesions which were assigned to treatment with bleomycin or placebo. Anatomical locations included the abdomen (n = 1), neck (n = 1), upper extremity (n = 2), chest (n = 4), and shoulder (n = 6). All patients completed the three consecutive treatments. However, one patient was lost to follow-up and missed the follow-up visit. Scar volume by 3D imaging 3D-imaging showed a statistically significant reduction in volume (p< 0.01) in bleomycin treated lesions, compared to placebo treated lesions (Figure 1-2a; Table 2). The baseline volume of the included lesions was 465.4 mm3, and was reduced with 20% in the bleomycin treated lesions at follow-up (LSM -91.0 mm3; CI -122.3, -61.5 mm3). In contrast, a slight increase in volume of +3% was observed in the placebo treated lesions at follow-up (LSM +13.4mm3; CI = -17.0, 43.90). Consistent with the volume results, statistically significant changes were observed in lesion height (Table 2). POSAS POSAS scores were filled in by the patients and physicians during all visits from baseline up to follow-up. Data on the changes over time are displayed for bleomycin vs. placebo treatment in Table 2, Figure 2c-d, and Table S2. The total POSAS patient score was 47.3 at baseline, and was reduced with 28% (LSM -13.3; CI -17.3, -9.4; p = 0.0344) at follow-up for the bleomycin treated lesions, versus a reduction of 16% (LSM -7,8; CI -11.8, -3.9) for those lesions treated with placebo. For the patient POSAS, the parameters, itch (-62.2%; LSM -2.8; CI -3.9, -1.7; p = 0.044), thickness (-39.7%; LSM-2.7; CI -3.8, -1.7; p = 0.018) and overall opinion (-28%; LSM -2.3;
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