Ingenol mebutate gel for the treatment of actinic keratosis is an effective adjunct therapy to cryosurgery, and the absence of attendant serious local reactions can increase compliance, based on data from more than 100 patients.
"By the time you do see a reaction, because the treatment time is only 2 or 3 days, the patient is done applying it, so the compliance is increased," Dr. Miriam S. Bettencourt, a community-based dermatologist in Las Vegas.
Dr. Bettencourt conducted her chart review of 135 patients "out of curiosity," she said in an interview. She found that at follow-ups of 1-4 months, nearly 100% of patients who received ingenol mebutate gel as an adjunctive therapy with cryosurgery for AK on the face had clearance rates of at least 75%. In addition, clearance of at least 75% was seen in 89% of patients treated on the scalp and 84% of patients treated on the forearms and/or hands. Most of the patients were male (88%), ranging in age from 39 to 85 years, with a median age of 70 years.
"One of the questions I had was, in a clinical practice, whether [the gel] mimics the clinical trial results that showed only a mild to moderate reaction," said Dr. Bettencourt. Common side affects of topical AK treatments include erythema, flaking, scaling, and crusting. In more extreme cases, vesicular pustulation is possible.
"I found that patients really didn’t complain of pain," said Dr. Bettencourt. "Most local skin reactions were resolved within a week." She prescribed moisturizers for patients whose reactions were moderate.
The findings were published in the March issue of the Journal of Drugs in Dermatology (J. Drugs Dermatol. 2014:13:269-73).
The results negate the common tenet that the more severe the reaction to the topical, the deeper the healing of the AK, said Dr. Bettencourt. "The degree of reaction does not correlate with the level of improvement. We used to think so, but that’s not true." The results show that the reaction can be "tolerable" and short lived despite dramatic results, she said.
The gel was approved by the Food and Drug Administration for use in the United States in early 2012 under the name Picato (LEO Pharmaceuticals). Unlike other topicals that must be applied over the course of weeks, the gel is applied for 2 or 3 days, with side effects lasting much of that time.
In addition to increased compliance, Dr. Bettencourt said she also measured whether her off-label "creativity" such as prescribing higher concentrations for the scalp and instructing patients to spread the gel over larger areas, yielded worthwhile results.
"I found that, especially for the face, you can spread the medication without jeopardizing the efficacy," said Dr. Bettencourt. However, when the gel is applied to the scalp, "You lose a little bit of the efficacy, because that’s a lot to cover using the prescribed three tubes, but you still get good results."
In addition, Dr. Bettencourt said that the gel offers cosmetic advantages over other treatments such as the topical imiquimod or photodynamic therapy because there is no hypo- or hyperpigmentation. And, because there is no photosensitivity associated with the gel, Dr. Bettencourt said she can offer it year-round.
She still prescribes other topicals, however, because not all patients’ insurance plans cover the gel. Medicare, does cover the gel, she noted, but only if the patient has a supplemental insurance policy.
While the study was unsponsored, and Dr. Bettencourt had no financial conflicts to disclose, she noted that she has shared her data with LEO Pharmaceuticals, the gel’s manufacturer. "They were thrilled, and helped me to put the results together," she said.
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