ABSTRACT
Bleomycin is widely used as an off-label treatment for various dermatologic 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 dermatologic indications with the aim to provide evidence-based recommendations for clinical practice. The PubMed, Embase, Medline Ovid, Web of Science, Cochrane Central, and Google Scholar databases were systematically searched. Two authors independently selected relevant studies according to predefined inclusion and exclusion criteria. We assessed the methodologic quality with the Cochrane Collaboration risk-of-bias assessment tool and selected 10 randomized clinical trials and 15 clinical controlled trials. Treatment indications included common warts, nonmelanoma skin cancer, cutaneous metastases, keloid and hypertrophic scars, and hemangioma. Intralesional bleomycin treatment showed significantly higher cure rates for warts compared with other treatments. Local adverse events included erythema, blackening, eschar formation, and superficial ulceration. None of the studies reported systemic adverse events. Methodologic 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 a successful and well-tolerated treatment for recalcitrant warts.
Subject(s)
Bleomycin/administration & dosage , Cicatrix, Hypertrophic/drug therapy , Hemangioma/drug therapy , Keloid/drug therapy , Skin Neoplasms/drug therapy , Warts/drug therapy , Bleomycin/adverse effects , Erythema/chemically induced , Erythema/epidemiology , Humans , Injections, Intralesional/adverse effects , Randomized Controlled Trials as Topic , Skin Pigmentation/drug effects , Skin Ulcer/chemically induced , Skin Ulcer/epidemiology , Treatment OutcomeABSTRACT
BACKGROUND AND OBJECTIVE: Pulsed Dye Laser (PDL) is currently the gold standard treatment for port wine stains (PWS), although the degree of lesion blanching is variable and often unpredictable. This appears to be due to reformation and reperfusion of blood vessels. Rapamycin has shown potential as an antiangiogenic agent and may prevent the revascularization after PDL treatment. The objective of this study was to evaluate the efficacy of adjuvant use of (commercially available) topical rapamycin after PDL treatment in patients with PWS. MATERIALS AND METHODS: We conducted a prospective, intra-patient, randomized controlled trial. Four treatment areas of 1 cm2 were created in each PWS. PDL-only treatment was compared to the following three treatments: PDL + rapamycin, PDL + Erbium YAG laser ablation of the stratum corneum + rapamycin, and rapamycin monotherapy. We also compared PDL + Erbium YAG + rapamycin with PDL + rapamycin. The primary endpoint was the percentage clearance assessed colorimetrically at 6 months follow-up. Secondary outcomes were photographic evaluation by an expert panel, patient satisfaction, treatment related pain, and safety. RESULTS: Fourteen patients completed the treatment protocol. The highest percentage clearance was achieved with PDL-only treatment (mean [SD] 16% [34]), but there were no statistically significant differences between treatments. The best photographic evaluation and highest patient satisfaction were also achieved with PDL-only treatment, but only the difference between PDL-only and rapamycin monotherapy was statistically significant. The treatment related pain was well tolerated. Application-site pruritus was a frequent occurring adverse event. Allergic contact dermatitis to rapamycin occurred in one patient. There were no serious adverse events. CONCLUSION: Topical application of the commercially available solution of rapamycin (Rapamune® 0.1%) as an adjuvant to PDL treatment does not appear to improve PWS blanching. Lasers Surg. Med. 49:104-109, 2017. © 2016 Wiley Periodicals, Inc.
Subject(s)
Lasers, Dye/therapeutic use , Lasers, Solid-State/therapeutic use , Low-Level Light Therapy/methods , Sirolimus/therapeutic use , Academic Medical Centers , Administration, Topical , Adolescent , Adult , Biopsy, Needle , Esthetics , Female , Follow-Up Studies , Humans , Immunohistochemistry , Male , Middle Aged , Netherlands , Port-Wine Stain/pathology , Port-Wine Stain/therapy , Prospective Studies , Statistics, Nonparametric , Treatment Outcome , Young AdultABSTRACT
Lentigo maligna (LM) is considered a precursor to LM melanoma (LMM). We assessed trends in LM and LMM incidence rates between 1989 and 2013 in the Netherlands, and estimated the risk of an LMM after LM. Data on newly diagnosed LM and LMM were obtained from the Netherlands Cancer Registry and PALGA: Dutch Pathology Registry. Age-standardized incidence rates (European standardized rate), estimated annual percentage changes, and the cumulative incidence of LMM after LM were calculated. Between 1989 and 2013, 10,545 patients were diagnosed with a primary LM and 2,898 with a primary LMM in the Netherlands. The age-standardized incidence rate for LM increased from 0.72 to 3.84 per 100,000 person-years, and for LMM from 0.24 to 1.19 between 1989 and 2013. LM incidence increased from 2002 to 2013 with 6.8% annually, before an even steeper rise in LMM incidence from 2007 to 2013 (estimated annual percentage change: 12.4%). The cumulative incidence of LMM after a primary LM after 25-year follow-up was 2.0% for males and 2.6% for females. The increased incidence of LM and LMM in the Netherlands seems, besides increased awareness and increased histological confirmation of LM, to reflect a true increase. The absolute risk of an LMM (at any location) after a histologically confirmed LM was low (2.0-2.6%).