Efficacy and safety of the innovative cold atmospheric-pressure plasma technology in the treatment of keloid: A randomized controlled trial.

Abstract

Keloid (KD) treatment is challenging for both physicians and patients. It can be functional debilitating and psychologically distressing. Available current therapeutics modalities give inconsistently effective results. To evaluate the efficacy and safety of innovative cold atmospheric plasma (CAP) technology in the treatment of keloid. This prospective, randomized control trial, the assessor-blinded trial, includes 18 patients with keloids. The keloid lesion was divided into two halves. One side was randomly treated with CAP technology biweekly on the same treated side for five sessions with a follow-up 30 days after finishing the final treatment. Another half was left untreated as a control. Efficacy assessment using POSAS, VSS, Patients' satisfaction scale, Antera 3D® skin imaging system. The safety assessment using VAS and adverse effects monitoring was completed. Objective assessment using Antera 3D® skin imaging system (Miravex, Dublin, Ireland) showed statistically significant improvement (p-value <0.05) on the treated side compared with the untreated side in all parameters, color, melanin, hemoglobin, texture, except for volume. POSAS, patient, and observer overall opinion score, and patient and observer total score in the summary of all rated characteristics, comparing the treated and untreated areas, showed a statistically significant reduction in all parameters after two treatments (*p-value <0.05). VSS showed statistically significant improvement after the second treatment and continued to the last follow-up. Most patients rated satisfaction scales up to 72.2% as moderate improvement, 11.1% as great improvement, 11.1% as slight improvement, and 5.6% as no change. The adverse effect was only a small scab in one patient. CAP technology could be considered an alternative treatment for keloid offering mild-to-moderate improvement with minimal side effects.