Assessing Patients’ Satisfaction With Hydrogen Peroxide Topical Solution, 40% for Treatment of Raised Seborrheic Keratoses

December 2020 | Volume 19 | Issue 12 | Original Article | 1184 | Copyright © December 2020


Published online November 25, 2020

Janet DuBois MDa, Kimberly Grande MD FAADb, Thomas Rhodes PhD MSPHc, Judith Schnyder MBAd, Stuart D. Shanler MD FAAD FACMSd

aDermResearch, Inc., Austin, TX
bThe Skin Wellness Center, Knoxville, TN
cTxR Data Science, Spring House, PA
dAclaris Therapeutics, Inc., Wayne, PA

Abstract
Objectives: Assess participants’ satisfaction following treatment with a proprietary hydrogen peroxide topical solution 40%, w/w (HP40) for raised seborrheic keratoses (SKs).
Methods: In this Phase 4, open-label study, eligible participants aged 30–75 years had clinically typical raised SKs including 2 target SKs (Physician’s Lesion Assessment™ [PLA] grade of ≥2 [0 = clear; 1 = near clear; 2 = thin (≤1 mm); 3 = thick (>1 mm)]; 5–15 mm diameter) on the face and 1 target SK on the neck or décolletage. SKs received HP40 treatment on day 1. All SKs with PLA grade ≥1 were retreated on days 15 and 29. Endpoints included patients’ satisfaction with their skin’s appearance at day 113, relationships between patients’ satisfaction and lesion PLA grade (evaluated by chi-square test), and patients’ satisfaction with their treatment experience.
Results: Forty-one patients (mean [range] age, 62.4 [46–73] years) completed the study. 95% of patients were at least moderately satisfied with their skin’s appearance and 90.2% of target lesions were clear. A statistically significant association was observed between the number of target lesions achieving clearance and patients’ satisfaction with skin appearance level (χ2=22.03; P=0.001). 93% of patients were at least moderately satisfied with their HP40 treatment experience. Eight patients experienced treatment-emergent adverse events (TEAEs), most of which were mild or moderate; 4 experienced TEAEs considered treatment-related.
Conclusions: Most patients with SKs on the face, neck, and décolletage were satisfied or very satisfied with both their skin’s appearance and their treatment experience following HP40 treatment. These results support the use of HP40 for raised SKs.

J Drugs Dermatol. 2020;19(12):1184-1191. doi:10.36849/JDD.2020.4974

INTRODUCTION

Seborrheic keratoses (SKs) are some of the most common benign dermatologic lesions seen by dermatologists in everyday practice,1,2 affecting approximately 84 million individuals in the United States.1-3 SK lesions typically present as sharply demarcated papules or plaques that appear stuck on the surface of the skin. These lesions generally range in color from light tan to dark brown and usually have a raised surface with a rough texture.1,2,4 SKs can occur anywhere on the body except the palms and soles, but most commonly occur on the face, neck, and trunk.1,2

SKs are benign lesions but are often cosmetically bothersome to patients, and individuals are more frequently seeking treatment for non-symptomatic SKs in order to have a more youthful appearance and better quality of life.5 In a recent observational study conducted across 10 dermatology practices in the United States, 61% of patients with non-symptomatic SKs reported having taken actions to disguise their lesions and 53% of patients reported having non-symptomatic SKs removed because they did not like their appearance.2 Additionally and expectedly, skin appearance after SK treatment may be an important factor in a patient’s decision to seek treatment. When patients were shown before and after treatment photos for SKs and were then asked how interested they would be in a treatment that gave them similar results, 86% expressed interest in pursuing such an option.2

Current treatment options for raised SKs are typically surgical or ablative, and include liquid nitrogen cryotherapy, shave removal, curettage, chemical peels, and laser treatments.2 However, surgical and ablative therapies can be invasive and may result in adverse effects such as local edema and crusting, infection, scarring, recurrence, and pigmentary changes.1 Among individuals who chose not to treat their SKs, the risks of several of these effects, especially scarring and pigmentary changes, have been reported as reasons they avoided treatment.2