Comparison of therapeutic effects and immunity of topical hydrogen peroxide solution (40% vol) with cryotherapy in seborrheic keratosis

Abstract

seborrheic keratosis or SK are common and benign tumor of the epidermis that can be seen routinely in middle-aged men and women. According to histological findings, if a lesion suddenly changes in size, shape, or number, or sudden clinical symptoms appear in the patient, it leads to increased concern about the malignancy of the lesion, and the lesion indicates removal. Other reasons for removing SK include itching and erythema. The current study aims to compare the therapeutic and safety effects of topical hydrogen peroxide solution (40% vol) with cryotherapy in seborrheic keratosis lesions. Materials and Methods: In this unblinded Phase 3 randomized clinical trial, 90 patients were included in the study based on the inclusion and exclusion criteria and were randomly divided into two intervention and control groups. Patients of the control group received the standard treatment of adult seborrheic keratosis (cryotherapy) based on the discretion of the attending physician. Patients in the intervention group received local hydrogen peroxide solution (40% vol). The study of the safety of drug use was based on drug side effects or TEAEs and local skin reactions or LSRs. The effectiveness of the treatment was evaluated by the PLA scale. Patients were evaluated at the time of the first visit, 3 weeks later, 6 weeks later, and 8 weeks after receiving the treatment. Results: The average age of the patients was 60.42 ± 12.87 years and 63.3% of them were female. After treatment in the group receiving HP40, the most common side effects are related to hypopigmentation (13.3%), erythema (11.1%), and scaling (8.9%). On the other hand, the most common complication related to cryotherapy was a pain in the area, followed by hypopigmentation (13.3%) and scaling (6.7%). Also, more than 90% of the side effects observed were of mild to moderate severity. In the group receiving HP40, after two rounds of treatment, 9.8% of patients had a PLA score of 0, after 3 rounds of treatment, 15.6% of patients had a PLA score of 0. In contrast, these values in the group receiving cryotherapy treatment were 13.3% and 22.2%, respectively. Also, the final treatment result was 26.7% in the HP40 group and 31.1% in the cryotherapy group; So these patients had PLA=0 at the end of the 8th week.