Multiple interventions are available for the treatment of actinic keratosis (AK) showing high efficacy in pivotal trials. However, data from post-marketing surveillance studies have received little attention until now. Here, we systematically investigate interventions for AK from post-marketing surveillance trials as a proxy for real-world efficacy and tolerability. A systematic literature search was conducted in Medline, Embase, and CENTRAL. Pertinent trial registers were hand-searched until 25 March 2020. Results were pooled using a random-effects model to calculate pooled proportions and relative risks (RR) or were described qualitatively. Eleven records with a total sample size of n = 4109 were included. Three of the studies had an active-controlled design, while seven were single-armed. Participant complete clearance ranged from 23.1% for diclofenac sodium 3% gel to 88.9% for ingenol mebutate 0.05% gel. The lesion-specific clearance rate for photodynamic therapy (PDT) was 74% (95% confidence interval (CI) 56–87%). The recurrence rate was significantly higher for diclofenac sodium 3% in comparison to imiquimod 5% cream (RR 1.10, 95% CI 1.02–1.1.8) and ranged from 10.6% for ingenol mebutate 0.015% gel to 23.5% for PDT. Few patients discontinued the trials due to adverse events. The results from the majority of the post-marketing surveillance studies deviated from those of pivotal trials.

and 15Á5% reporting, respectively. However, our results show persistent under-representation of patients with skin of colour. Limitations of the study include incomplete race/ethnicity reporting, which may misrepresent certain groups. Race is also currently broadly categorized (white, black etc.). While individuals within the same racial groups share phenotypic and genetic characteristics, variations exist within racial subgroups (e.g. South Asian, East Asian). As globalization continues, evolving definitions of race and ethnicity are needed. Bhattacharya and Silverberg found potential differences in the efficacy of nonbiologic systemic AD treatments based on racial or ethnic subgroups. 8 With over 25 pipeline AD medications under investigation, 3 AD treatments provide a unique window for identifying gaps to improve future RCTs. Low representation of patients with skin of colour in clinical trials limits the generalizability of trial outcomes. Including trial sites within diverse areas, promoting awareness to patients with skin of colour, standardizing race/ethnicity classifications, and including race/ethnicity subanalysis can all help to encompass global racial and ethnic heterogeneity better. While progress has been made to diversify AD trials, our results highlight continued under-representation of patients with skin of colour. By encouraging transparent reporting of race and ethnicity data, practitioners may provide more individualized patient care and improve patient outcomes.