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)

Abstract

Ingenol mebutate is effective for the treatment of AK in Asians, with tolerable safety profiles.

A Systematic Review and Meta-Analysis of Interventions for Actinic Keratosis from Post-Marketing Surveillance Trials

“…The diagnosis of AK was made clinically in n = 3378, histopathologically in n = 556 and both clinically and histopathologically in n = 175 patients. Three of the studies had an active-controlled design [ 16 , 17 , 18 ], while seven were single-armed [ 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 ] ( Table 1 ). The study by Gollnick et al presented a pooled analysis of two similar phase IV studies (LEIDA 1 and 2) [ 17 ].…”

“…The study by Gollnick et al presented a pooled analysis of two similar phase IV studies (LEIDA 1 and 2) [ 17 ]. All studies assessed AK located on the face or scalp; three studies investigated AK located on the extremities or the trunk as well [ 20 , 23 , 25 ]. The studies were published between 2006 and 2019.…”

“…However, the two studies investigating PDT differed, as they used either ALA-patch or a topical ALA solution. The remaining studies compared cryosurgery monotherapy with cryosurgery followed by diclofenac/HA [ 16 ], imiquimod 5% cream with diclofenac/HA [ 17 ], IMB 0.015% gel with diclofenac/HA [ 18 ], and one study investigated IMB 0.015% and 0.05% [ 20 ]. Due to the differences of the study design and the heterogeneity of the included studies, meta-analysis was performed for two single-armed studies on diclofenac/HA [ 19 , 21 ] and ALA-PDT [ 24 , 26 ], respectively.…”

“…In a single-armed study, one-third of the patients treated with ALA-PDT achieved complete clearance (33.6%) ( Table 2 and Table 3 ) [ 26 ]. The participant complete clearance for IMB was 76.6% for lesions located in the face [ 20 ] and 88.9% [ 20 ] for lesions on the trunk or the extremities. Cryosurgery in combination with diclofenac/HA was more effective in achieving participant complete clearance than cryosurgery monotherapy (RR 1.65, 95% CI 1.33–2.04) [ 16 ].…”

“…The recurrence rate was significantly higher for diclofenac/HA in comparison to imiquimod 5% cream (RR 1.10, 95% CI 1.02–1.1.8) [ 17 ]. For IMB applied to the face or the scalp, there was a recurrence rate of 10.6%, and for IMB applied to the trunk or the extremities, a recurrence rate of 28.6% was reported [ 20 ]. In total, 23.5% of lesions recurred in patients who had undergone ALA-PDT [ 26 ].…”