Phase IV head-to-head randomized controlled trial comparing ingenol mebutate 0·015% gel with diclofenac sodium 3% gel for the treatment of actinic keratosis on the face or scalp

Abstract

AKCLEAR 100, patient treatment satisfaction and effectiveness were significantly higher with IngMeb compared with DS, demonstrating superiority of IngMeb for AK treatment on face/scalp.

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 ].…”

“…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.…”

Response to ‘Phase IV head-to-head randomized controlled trial comparing ingenol mebutate 0·015% gel with diclofenac sodium 3% gel for the treatment of actinic keratosis on the face or scalp’

“…Linked article: Br J Dermatol 2018; https://doi.org/10.1111/ bjd.16048. DEAR EDITOR, We read with attention the recent paper by Stockfleth et al 1 on the efficacy and safety of ingenol mebutate 0Á015% gel (IngMb) vs. diclofenac sodium 3% gel (DS) for the treatment of actinic keratosis (AK). Regarding this interesting study, we would like to address some comments to the authors.…”

“…6 in our article). 1 Whereas AEs were assessed at both follow-up visits in the IngMeb group, Treatment Satisfaction Questionnaire for Medication (TSQM) scores were assessed only at week 17. Caution should always be exercised when making comparisons with other studies, but the TSQM scores observed in our study are in line with the scores reported in studies where the TSQM assessment was made 8 weeks after the start of treatment.…”

Response to ‘Phase IV head-to-head randomized controlled trial comparing ingenol mebutate 0·015% gel with diclofenac sodium 3% gel for the treatment of actinic keratosis on the face or scalp’: reply from the authors

“…6 in our article). 1 Whereas AEs were assessed at both follow-up visits in the IngMeb group, Treatment Satisfaction Questionnaire for Medication (TSQM) scores were assessed only at week 17. Caution should always be exercised when making comparisons with other studies, but the TSQM scores observed in our study are in line with the scores reported in studies where the TSQM assessment was made 8 weeks after the start of treatment Abstracts of papers and posters should be submitted for consideration by the Scientific Committee.…”