Needle-Free Jet Injector with Bleomycin Proves Effective and Patient-Friendly for Severe Keloids in Recent Study
Netherlands: A recent study has revealed that Intralesional bleomycin administered via a needle-free electronic pneumatic jet injector (EPI) is effective and well-tolerated for treating keloid patients. The randomized, double-blind, placebo-controlled trial highlights a promising advancement in dermatological treatment options for this challenging condition.
"Three treatments using the EPI with bleomycin have proven effective and well-tolerated for severe keloids. Additionally, the majority of patients preferred EPI treatment, suggesting it could be a more patient-friendly alternative," the researchers wrote in Clinical and Experimental Dermatology.
Treating severe keloids poses significant challenges, as corticosteroid injections can be painful and are often accompanied by frequent recurrences. Consequently, there is an urgent need for more effective, safe, and patient-friendly alternative treatments.
The needle-free jet injector offers several advantages over conventional methods. By eliminating the need for needles, it addresses one of the major sources of patient discomfort and anxiety. This approach also reduces the risk of needle-related complications and may improve overall patient compliance.
Against the above background, Vazula Z Bekkers, University Medical Center Rotterdam, Rotterdam, the Netherlands, and colleagues aimed to assess the tolerability, efficacy, and patient satisfaction of intralesional bleomycin treatment using a needle-free EPI in severe keloids.
The double-blind, randomized placebo-controlled trial with split-lesion design included patients with severe keloids. Three EPI treatments, using bleomycin or saline, were administered every four weeks on the respective intervention and control sides. Fourteen patients (nine female, five men) were included.
Outcome measures included changes in scar volume evaluated through 3D imaging, the Patient and Observer Scar Assessment Scale (POSAS), skin perfusion assessed by laser speckle contrast imaging (LSCI), spilled volume, procedure-related pain, adverse events, and patient satisfaction.
The following were the key findings of the study:
- The estimated mean keloid volume was significantly reduced by 20% after EPI-assisted bleomycin, compared to a slight increase of 3% in the control side.
- The estimated mean POSAS patient and observer scores reduced, by 26% and 28%.
- 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 NRS pain scores were moderate.
- Adverse events included bruising, hyperpigmentation, and transient superficial necrosis.
The findings showed that treatment with intralesional bleomycin using a needle‐free electronic pneumatic jet injector is well-tolerated and effective among keloid patients.
"This promising development could pave the way for broader adoption of needle-free technologies in medical treatments, offering hope to those suffering from severe keloids and potentially transforming the landscape of dermatological care," the researchers concluded.
Reference:
Bekkers, V. Z., Zdunczyk, K. M., Bik, L., Ten Voorde, W., Aarts, P., Oerlemans, F., Bohoslavsky, R., Haedersdal, M., Prens, E. P., Rissmann, R., & Van Doorn, M. B. Needle-free jet injector treatment with bleomycin is efficacious in patients with severe keloids: A randomized, double-blind, placebo-controlled trial. Clinical and Experimental Dermatology. https://doi.org/10.1093/ced/llae254
