Topical hydrogen peroxide safe, well-tolerated for seborrheic keratosis
A 40-percent hydrogen peroxide topical solution (HP40) effectively and safely removes seborrheic keratoses (SK), according to a recent study.
In two identical phase 3 pivotal studies, researchers randomly assigned 937 SK patients each with four lesions to receive either HP40 (n=467; mean age 68.3±8.68 years; 61.2 percent female) or vehicle control (n=470; mean age 69.1±8.67 years; 55.7 percent female). The Physician’s Lesion Assessment (PLA) scale was used to grade SKs, and lesions that were graded above zero after initial treatment were retreated 3 weeks later.
Significantly more participants in the HP40 group achieved a PLA score of 0 in all four lesions than in the control group in both the first (4 percent vs 0 percent; p<0.01) and second (8 percent vs 0 percent; p<0.01) pivotal studies. Similar findings were observed for complete clearance in three of four lesions (study 1: 13 percent vs 0 percent; study 2: 23 percent vs 0 percent; p<0.0001 for both).
Notably, 25.0 percent of all SK lesions in the HP40 group achieved a PLA score of ≤1 after the first treatment.
In terms of safety, pooled analysis of both studies revealed that 21 percent of all HP40 participants reported 145 treatment-emergent adverse events (TEAEs), compared with only 126 TEAEs in 88 patients in the vehicle control group. Most of the TEAEs were either mild or moderate in intensity.
Three TEAEs in the HP40 group were identified as severe and related to the study medication. One case was of pain at the application site, another was of burning from treatment and the final one was of burning sensation.