Ingenol mebutate in low amounts for the treatment of actinic keratosis in Korean patients

Abstract

BackgroundIngenol mebutate (IM), a novel agent for field therapy of actinic keratosis (AK), has a drawback of inducing local skin reactions (LSRs), which may cause discomfort in patients. To reduce the LSRs, we tried the application of IM in low amounts.ObjectiveThe purpose of this study was to review Korean patients with AK being treated with IM and evaluate the LSRs and therapeutic outcomes of low amounts of IM.MethodsWe retrospectively reviewed 47 patients with AK on the face. A total of 20 and 27 patients were treated by applying recommended amount of 18.8 mg/cm2 and the lower amount of 10 mg/cm2, respectively.ResultsThe mean composite LSR score for the low amount group (LAG; 12.18±3.29) was significantly lower than that for the recommended amount group (RAG; 15.45±2.70) (P<0.01, independent sample t-test). The 2-month clearance rate calculated by the number of AKs before and after treatment in each patient was significantly higher for RAG (88.16%), compared with 75.56% for LAG (P<0.001).ConclusionLow amount of IM for the treatment of facial AK significantly reduced LSRs in Korean patients. Minimizing LSRs may allow for a secondary targeting treatment of IM for the residual lesions, depending on initial treatment outcomes.

A multicentre, open, investigator-initiated phase IV clinical trial to evaluate the efficacy and safety of ingenol mebutate gel, 0·015% on the face and scalp, and 0·05% on the trunk and extremities, in Korean patients with actinic keratosis (PERFECT)

“…In the study targeting white patients, the mean maximum composite LSR score was 9·1 ± 4·1 in the face/scalp group and 6·8 ± 3·5 in the trunk/extremities group. A high LSR score in the present study is consistent with a previous retrospective study with Korean patients . It can be explained by the fact that Asian skin has a weak skin barrier function, which is responsible for the prevention of the penetration of toxic, sensitizing or irritant substances into the skin .…”

“…However, as AK is more common in white populations, most of the pivotal studies have targeted people with white skin. There was a retrospective study conducted to investigate the efficacy and local skin responses (LSRs) in Korean populations, but it was not a large‐scale study . The efficacy and especially the safety profile may be different in Asian populations from Western populations.…”

Evaluation of Different Approaches in Managing Local Skin Reactions With the Use of Ingenol Mebutate 0.015% and 0.05% During the Treatment of Actinic Keratosis

“…• The 6 studies selected for the analysis represented a range of study designs (Table 1) -Retrospective chart reviews 1,6,7 n=3 -Randomized controlled trial 8 n=1 -Investigator-initiated single-blinded study 9 n=1 -Observational longitudinal cohort study 10 n=1 • The 6 studies examined a total of 1437 patients; 1424 patients were evaluated for LSRs associated with IMB • 3 of the studies only examined the resolution of LSRs over time in the absence of any intervention 6,7,10 • The other studies evaluated different approaches in managing or minimizing LSRs during the treatment of AK -Use of various topical moisturizers 1,2,10 -Implementing a low-dose regimen of IMB 6 -Application of dimethicone 9 -Application of clobetasol propionate 8…”

Prevalence, Discontinuation Rate, and Risk Factors for Severe Local Site Reactions with Topical Field Treatment Options for Actinic Keratosis of the Face and Scalp

“…Other proposed risk factors for greater severity of LSRs with IngMeb are: the female gender, an age below 70 years, and Korean patients [41]. This last observation was suggested to be related to the difference of race and skin thickness [42]. The importance of environmental factors has been suggested in a study by Fargnoli et al conducted in Italy from September to October.…”