Use of Ingenol Mebutate Gel for Actinic Keratosis in Patients in a Community Dermatology Practice
March 2014 | Volume 13 | Issue 3 | Original Article | 269 | Copyright © March 2014
Miriam S. Bettencourt MD
Bettencourt Skin Center, Henderson,
NV University of Nevada, Las Vegas, NV
BACKGROUND: Ingenol mebutate gel is a topical field treatment for actinic keratosis (AK) approved for a 2- or 3-day duration of application.
OBJECTIVE: This chart review examined the efficacy and safety of ingenol mebutate gel for treatment of AK in patients from a community dermatology practice.
METHODS: A retrospective chart review was conducted for all patients with AK treated with ingenol mebutate gel.
RESULTS: A total of 135 patients with a prolonged history of AK were treated from April 2012 to January 2013. The majority received cryosurgery to all visible lesions, followed 2 weeks later by ingenol mebutate; areas treated with ingenol mebutate were typically >25 cm2 in size. Local skin reactions, consisting of mild to moderate erythema and flaking/scaling, were significantly improved by 1 week after peak inflammation and were not treated in most patients. At 1 to 4 months after treatment of AKs on the face, nearly all patients (99%) achieved ≥75% clearance of baseline and emergent AKs. After treatment of AKs on the scalp or forearm and/or hand, >80% of patients demonstrated ≥75% clearance.
LIMITATIONS: This was a retrospective chart review of patients from a single practice.
CONCLUSION: Ingenol mebutate is an effective, well-tolerated topical treatment for AK in sun-damaged skin. J Drugs Dermatol.
Patients with heavily sun-damaged skin frequently have a substantial burden of actinic keratosis (AK) and subclinical AKs that are commonly treated with topical therapy to target large areas. Although cryosurgery with liquid nitrogen continues to be the most frequently used method to treat AKs,1,2 it cannot treat the perilesional sun-damaged skin, which can be the source of future AKs. Pharmacologic topical creams and gels can treat both clinically apparent and subclinical lesions in sun-damaged skin. All of the topical agents used to treat AK cause a localized inflammatory skin reaction as a result of the therapeutic activity
that eliminates transformed keratinocytes.3-6 Since many topical agents require application for several weeks, during which local skin reactions (LSRs) may persist, patients who are unable to tolerate these prolonged skin reactions may discontinue treatment early and not achieve the expected clearance rates. Ingenol mebutate gel has a short treatment regimen of 2 or 3 days. The 0.015% gel is applied once daily for 3 days to the face or scalp, while the 0.05% gel is applied once daily for 2 days to the trunk or extremities.7 Rates of complete clearance in phase 3 studies of ingenol mebutate gel6 have been similar to those observed with agents that are used for longer periods of time.3,5
Treatment strategies that include both lesion-directed and field-directed therapies may increase the likelihood of treatment success.8,9 The purpose of this analysis was to retrospectively review the charts of patients treated in a community
dermatology practice in order to describe the efficacy and safety of their treatment with ingenol mebutate gel.
Patient demographics, medical history, pertinent history of AK and skin cancer, and information on treatments for those conditions
were collected by chart review. Data on the current course of treatment with ingenol mebutate gel, including size and location
of treatment area(s), efficacy, and follow-up, were assessed and summarized. Complete clearance, 100%, was defined as the absence of any baseline and emergent AKs, while clearance ≥75% or ≥50% denoted the approximate reduction from baseline
in the number of AKs. Clearance rates were then defined as the percent of patients with either complete or partial clearances.
Charts were also reviewed for adverse events and the severity, onset, duration, and treatment of LSRs. LSRs were classified
as mild, moderate, or severe. Patients were informed of the potential for these reactions and received instructions on the use of over-the-counter moisturizers and/or steroid-sparing lipid-containing prescription creams. The correlation between the intensity of the LSRs and clearance of AKs was also assessed.
A total of 135 patients received ingenol mebutate gel from April 2012 to January 2013. Patients ranged in age from 39 to 85 years (median, 70 years), were predominantly male,