A lower concentration ingenol mebutate gel than is indicated to treat chest area actinic keratoses appears to significantly decrease lesion counts, without the sometimes severe skin effects from traditional treatment, according to a recent study.
Actinic keratosis patients, who applied ingenol mebutate gel 0.015% (Picato, Leo Pharma) to up to 100cm2 area of their chests once daily for three consecutive days, reduced actinic keratosis lesion counts by an average 76 percent compared to baseline. The treatment also improved signs of photoaging, achieved good patient satisfaction and was well tolerated, according to the study.
In August 2015, the FDA issued a safety warning about safety risks associated with ingenol mebutate gel — specifically, Picato, by Leo Pharma — based on reports of severe allergic reactions, including anaphylaxis, and herpes zoster in patients with actinic keratosis treated with the gel. The safety risks were associated with both the 0.015% and 0.05% concentrations. As a result, FDA recommended, among other things, that “Picato gel should only be used on one contiguous skin area of not more than approximately 25 cm2 (5 cm × 5 cm).”
The 0.05% ingenol mebutate formulation is indicated for use on the chest, applied once daily for two consecutive days. While it does clear actinic keratosis on a 25cm2 area, it continues to be associated with intense local skin responses. Even the authors write that they have observed poor tolerability of ingenol mebutate gel 0.05% on the chest — a notoriously difficult area to treat — particularly among women.
But they found good efficacy and safety when they used the lower concentration topical within specific parameters on the chest, according to the study.
In a small open-label study of 20 people, each who had four or more actinic keratoses on their chests in a contiguous area of less than 100 cm2, they write, local skin responses, including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation and erosion/ulceration, generally resolved within two weeks post treatment.
And many patients were left with not only fewer actinic keratoses but also younger looking skin. More than 60 percent of those studied indicated they were moderately or completely satisfied with their perceived improvements in photoaging. The authors write they also observed significant reductions in signs of photoaging on day 59, which was the last of six follow up visits, according to the study.
“As dermatologic surgeons, we always strive to treat our patients in the most efficacious, least expensive and least traumatic way possible. In our latest clinical study, we found both efficacy and safety of topical ingenol mebutate gel 0015% to treat actinic keratosis on the chest,” says study author Mitchel P. Goldman, M.D., volunteer clinical professor of dermatology, University of California, San Diego, and medical director of West Dermatology, San Diego.
The study was sponsored and funded by Leo Pharma, but the individual authors report no conflicts of interest relevant to the contents of the paper.
Wu DC, Guiha I, Goldman MP. A Prospective Pilot Clinical Trial to Evaluate the Efficacy and Safety of Topical Therapy with Ingenol Mebutate Gel 0.015% for Actinic Keratosis on an Expanded Area of the Chest. The Journal of Clinical and Aesthetic Dermatology. 2017. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5605212/