Needle-free jet injector treatment with bleomycin is efficacious in patients with severe keloids: a randomized, double-blind, placebo-controlled trial.
Vazula Z Bekkers, Katarzyna M Zdunczyk, Liora Bik, Wouter Ten Voorde, Pim Aarts, Femke Oerlemans, Roman Bohoslavsky, Merete Haedersdal, Errol P Prens, Robert Rissmann, Martijn B A van Doorn
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Abstract
Background: Severe keloids are difficult to treat. Corticosteroid injections with needles are painful and associated with frequent recurrences. Therefore, more effective, safe and patient-friendly alternative treatments are urgently needed.
Objectives: To assess the efficacy, tolerability and patient satisfaction of intralesional bleomycin treatment using a needle-free electronic pneumatic jet injector (EPI) in severe keloids.
Methods: Patients with severe keloids were included in this double-blind, randomized, placebo-controlled trial with split-lesion design. Three EPI treatments with bleomycin or saline were administered every 4 weeks in the intervention and control sides. Outcome measures were change in scar volume assessed by three-dimensional imaging, Patient and Observer Scar Assessment Scale (POSAS), skin perfusion with laser speckle contrast imaging (LSCI), spilled volume, procedure-related pain, adverse events and patient satisfaction.
Results: Fourteen patients (nine female, five male) were included. The estimated mean keloid volume was significantly reduced by 20% after EPI-assisted bleomycin, compared with a slight increase of 3% in the control side (P < 0.01). The estimated mean POSAS patient and observer scores decreased by respectively 28% and 20% (P = 0.03 and P = 0.001). LSCI showed no significant change in perfusion. EPI treatment was preferred over previous needle injections in 85% of patients. The estimated mean spilled volume after EPI was around 50%, and numerical rating scale pain scores were moderate. Adverse events included bruising, hyperpigmentation and transient superficial necrosis.
Conclusions: A course of three EPI-assisted bleomycin injections is efficacious and well tolerated in severe keloids. Moreover, EPI was preferred by most patients and may serve as a patient-friendly alternative treatment.
期刊介绍:
Clinical and Experimental Dermatology (CED) is a unique provider of relevant and educational material for practising clinicians and dermatological researchers. We support continuing professional development (CPD) of dermatology specialists to advance the understanding, management and treatment of skin disease in order to improve patient outcomes.