Needle-free jet injector treatment with bleomycin is efficacious in patients with severe keloids: a randomized, double-blind, placebo-controlled trial

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.