Department of Oncology, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
Center for Experimental Drug and Gene Electrotransfer (C*EDGE), Department of Clinical Oncology and Palliative Care, Zealand University Hospital, Roskilde, Denmark.
Dermatology. 2021;237(6):961-969. doi: 10.1159/000514307. Epub 2021 Mar 31.
Keloid scarring is a pathologic proliferation of scar tissue that often causes pruritus, pain, and disfigurement. Keloids can be difficult to treat and have a high risk of recurrence. Recent studies have shown promising results in the treatment of cutaneous metastases with intralesional calcium combined with electroporation (calcium electroporation). As calcium electroporation has shown limited side effects it has advantages when treating benign keloid lesions, and on this indication we performed a phase I study.
Patients with keloids were treated with at least 1 session of calcium electroporation and followed up for 2 years. Calcium was administered intralesionally (220 mM) followed by the application of eight 100-µs pulses (400 V) using linear-array electrodes and Cliniporator (IGEA, Italy). Treatment efficacy was evaluated clinically (size, shape, erythema), by patient self-assessment (pruritus, pain, other) and assessed histologically.
Six patients were included in this small proof of concept study. Treatment was well tolerated, with all patients requesting further treatment. Two out of 6 patients experienced a decrease in keloid thickness over 30%. A mean reduction of 11% was observed in volume size, and a mean flattening of 22% was observed (not statistically significant). Five out of 6 patients reported decreased pain and pruritus. No serious adverse effects or recurrences were observed over a mean follow-up period of 338 days.
In this first phase I clinical study on calcium electroporation for keloids, treatment was found to be safe with minor side effects. Overall, patients experienced symptom relief, and in some patients keloid thickness was reduced.
瘢痕疙瘩是一种病理性的瘢痕组织增生，常导致瘙痒、疼痛和毁容。瘢痕疙瘩的治疗较为困难，且复发风险高。最近的研究表明，在使用腔内钙联合电穿孔（钙电穿孔）治疗皮肤转移方面取得了有希望的结果。由于钙电穿孔的副作用有限，因此在治疗良性瘢痕疙瘩病变时具有优势，我们就在这一适应证上进行了一项 I 期研究。
至少接受过 1 次钙电穿孔治疗的瘢痕疙瘩患者接受了随访，随访时间为 2 年。通过线性阵列电极和 Cliniporator（IGEA，意大利）将腔内钙（220mM）给药，然后施加 8 个 100-μs 脉冲（400V）。通过临床（大小、形状、红斑）、患者自我评估（瘙痒、疼痛、其他）和组织学评估来评估治疗效果。
这项小型概念验证研究共纳入了 6 例患者。治疗耐受性良好，所有患者均要求进一步治疗。6 例患者中有 2 例的瘢痕疙瘩厚度减少了 30%以上。体积大小平均减少了 11%，平均平坦度为 22%（无统计学意义）。6 例患者中有 5 例报告疼痛和瘙痒减轻。在平均 338 天的随访期间，未观察到严重不良事件或复发。
在瘢痕疙瘩钙电穿孔的首次 I 期临床研究中，发现治疗具有安全性，副作用较小。总体而言，患者的症状得到了缓解，一些患者的瘢痕疙瘩厚度也有所减少。
