Photo by: Klaus D. Peter, via Wikimedia Commons
A systematic review of clinical trials has found that a 40% solution of hydrogen peroxide (HP40), as a treatment for seborrheic keratosis (SK), has a safety profile that makes it a valuable topical treatment alternative in cosmetically sensitive areas, despite its lower efficacy and higher cost than some other treatments for SK.
Published online ahead of print in Annals of Pharmacotherapy (July 10, 2020), the paper reviewed articles written in English between Jan. 2000 and mid-June 2020 discussing phase II and phase III clinical trials of HP40 in the treatment of SK.
In two phase III clinical trials, with a total 937 patients with 4 SKs each (≥1 lesion each on the face and on the trunk and/or an extremity), 4% and 8% of patients treated with HP40 had a Physician Lesion Assessment score of zero for all four SKs, respectively, at the primary endpoint at day 106. This compared to 0% of those in the two studies’ vehicle groups achieving Physician Lesion Assessment scores of zero (p<0.01; p<0.0001).
“HP40, although less effective, has a better safety profile than other treatment options. It should be especially considered for treatment of facial SKs, where it is most efficacious and where other treatment modalities, such as cryotherapy, are more challenging,” the authors write.
HP40 was approved as a topical treatment for SK by the U.S. FDA in Dec. 2017. A New Drug Submission was accepted for review by Health Canada in Dec. 2018.