8. General discussion 204 bleomycin intolerance, peripheral vascular diseases, pregnancy or lactation, and Raynaud phenomenon. The promising efficacy and safety profile of intralesional bleomycin administered with EPI according to previous pre-clinical studies led to the design of a randomized controlled trial (RCT). The efficacy, safety, and patient satisfaction of EPI-assisted bleomycin treatment in keloids are described in chapter 5. In this RCT we administered three treatments with EPI-assisted bleomycin in severe keloids. We found a reduction in keloid volume of 20% in bleomycin treated lesions, compared to a slight increase with placebo. Similarly, we found a significant reduction in keloid related symptoms with EPI-assisted bleomycin. However, there was no significant change in blood flow with bleomycin compared to placebo, and therefore we do not expect permanent changes in microcirculation with the used bleomycin dosage. Adverse events were mild and included hyperpigmentation, transient necrosis and hematoma. We concluded that EPI-assisted bleomycin treatment is an efficacious, safe and well tolerated treatment for patients with severe keloids. Up to date, no other studies have been published that use highly sensitive 3D measurements to assess changes in volume after intralesional bleomycin treatment in keloids. Therefore, we cannot directly compare our findings with previous results from literature. However, a previous RCT of Khan et al. compared six treatments of intralesional CNI-assisted bleomycin with triamcinolone in keloids and found a significant improvement in mean total POSAS of 72% vs 67%, respectively.17 The BLEOJET study shows some resemblance to the RCT of Erlendson et al., but administered a single treatment with 5-Fluorouracil using EPI to treat hypertrophic scars.9 A volume reduction of 33% in scar volume was detected with a 3D-camera in the hypertrophic scars that were treated with 5-Fluorouracil. Although this is considerably more than observed in our study, it is imported to highlight the significant differences between hypertrophic scars and severe keloidal scars, of which the latter is more often not responsive to treatment. Interestingly, injection-related pain scores with EPI-assisted bleomycin were still relatively high. NRS Pain scores were 5.4 and 5.6, in respectively the bleomycin and placebo treated
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