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Background  Actinic keratoses ( AK s) are precursors to invasive squamous cell carcinoma and can progress if untreated. Limited data support the use of ingenol mebutate to treat  AK s on more than one area of the body simultaneously.    Objective  To investigate safety, efficacy and treatment satisfaction when treating separate areas simultaneously or sequentially with different concentrations of ingenol mebutate gel.    Methods  In this phase  III b study ( NCT 01787383), patients with clinically visible, non‐hyperkeratotic  AK s on two separate treatment areas (face/scalp and trunk/extremities) were randomized to simultaneous or sequential treatment with ingenol mebutate gel (0.015% and 0.05%). Endpoints included composite local skin response ( LSR ) score 3 days after first application, complete  AK  clearance and percentage reduction in  AK s at week 8.    Results  There were no statistically significant differences between simultaneous ( n  = 101) and sequential ( n  = 98) groups in composite  LSR  score (10.4 vs. 9.7), complete clearance (52.7% vs. 46.9%) or percentage reduction in  AK s (83.4% vs. 79.1%). Mean composite  LSR  scores on face/scalp and trunk/extremities were similar for both groups. Adverse event ( AE ) incidence was comparable between groups, the most common treatment‐related  AE s being pruritus and pain at the application site.    Conclusion  Treating  AK s with ingenol mebutate simultaneously or sequentially gave similar results in terms of tolerability ( LSR  score,  AE s) and efficacy (complete clearance). Therefore, the physician and patient can select the most convenient treatment regimen, with confidence in achieving a similar outcome.

journal of the european academy of dermatology and venereology

A randomized trial comparing simultaneous vs. sequential field treatment of actinic keratosis with ingenol mebutate on two separate areas of the head and body