Cryotherapy Versus Intralesional Bleomycin in Keloids: A Randomized Controlled Trial Comparing the Effectiveness, Safety, and Quality of Life

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BACKGROUND: Keloid is a benign, well-demarcated overgrowth of fibrous tissue due to abnormal wound healing in response to cutaneous injury, hampering quality of life. Multiple treatment options are available with unsatisfactory results. Cryotherapy is limited by edema, swelling, blister formation, oozing, and depigmentation. Bleomycin, a cytotoxic antibiotic, induces apoptosis with sclerosing action on endothelial cells and inhibits collagen synthesis. AIM AND OBJECTIVES: The study compared the effectiveness, safety, and quality of life in patients of keloid receiving cryotherapy versus intralesional bleomycin. PATIENTS AND METHODS: It was an institution-based, open-labelled, randomized controlled trial (CTRI/2020/08/027352). The study included treatment naïve adult consenting patients with localized keloids, randomized (1:1) into group A (spray cryotherapy) or group B (intralesional bleomycin). Infected and ulcerated keloids were excluded. Six follow-up visits were conducted at 4 weekly intervals. Sample size was 26 in each arm. Decrease in thickness, Vancouver scar scale (VSS), patient and observer scar assessment scale (POSAS), dermatology life quality index (DLQI) were evaluated. RESULTS: Mean reduction in thickness was found to be significantly more in bleomycin in comparison to cryotherapy ( P < 0.001). VSS score was found to be significantly reduced in both the treatment arms ( P < 0.001) from first follow-up onwards. VSS was found to be significantly less (analysis of co-variance [ANCOVA] test, P < 0.001) in bleomycin in comparison to cryotherapy from third follow-up (12 weeks) onwards. POSAS observer score was found to be significantly less (ANCOVA test, P < 0.001) in bleomycin in comparison to cryotherapy. DLQI was significantly improved ( P < 0.001) in bleomycin. Bulla formation and depigmentation (cryotherapy); hyperpigmentation and procedural pain (bleomycin) were the main adverse events. LIMITATIONS: The study was conducted during the COVID period, which affected the follow-up. CONCLUSION: Both spray cryotherapy and intralesional bleomycin were safe and effective agents in keloid treatment. Intralesional bleomycin was a better alternative to spray cryotherapy in reducing lesional thickness, itching, pain, stiffness, surface area, scar irregularity, and color difference associated with keloids. Thus, intralesional bleomycin has the potential to be used as monotherapy for localized keloids.

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