Bleomycin is widely used as off-label treatment for various dermatological indications. However, a much-needed critical appraisal of the currently available evidence is lacking. We, therefore, evaluated the quality of clinical evidence for the efficacy and safety of intralesional bleomycin treatment for dermatological indications with the aim to provide evidence-based recommendations for clinical practice. A systematical database search in Pubmed, Embase, Medline Ovid, Web of Science, Cochrane central and Google Scholar was conducted. Two authors independently selected relevant studies according to predefined inclusion and exclusion criteria. We assessed the methodological quality with Cochrane Collaboration’s risk-of-bias assessment tool. Ten RCTs and 15 CCTs were selected. Treatment indications included; common warts, non-melanoma skin cancer, cutaneous metastases, keloid, hypertrophic scars and hemangioma. Intralesional bleomycin treatment showed significant higher cure rates for warts compared to other treatments. Local adverse events included erythema, blackening, eschar formation and superficial ulceration. None of the studies reported systemic adverse events. Methodological quality of the studies was generally low. Consequently, no firm recommendations can be made for intralesional bleomycin treatment in clinical practice. However, this review suggests that intralesional bleomycin is an successful and well-tolerated treatment for recalcitrant warts.
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