Topicaal ingenol mebutaat versus 5% 5-fluorouracil versus 5% imiquimod versus fotodynamische therapie als behandeling van actinische keratosen: Een multicenter gerandomiseerde kosten effectiviteitsstudie: het protocol van de AKTI-studie

To date, there is no consensus on the treatment of actinic
keratosis (AK). Current national and international guidelines
state no clear recommendations for the best choice
of therapy. To determine the most effective treatment in
terms of lesion reduction, costs and patient satisfaction
topical treatment with 0.015% ingenol mebutate gel, 5%
5-fluorouracil cream, 5% imiquimod cream and photodynamic
therapy were compared in a prospective randomized
controlled multi-centre study. Patients older than 18
years with a Fitzpatrick skintype I-IV, with 5 AK’s Olsen
class I-III in an area of minimal 25 cm2
and maximal 100
cm2
, localized in the head and neck area were included in
the study. In total 624 were included in the Dermatology
departments of the Maastricht University Medical
Centre, Catharina hospital Eindhoven, Zuyderland
Medical Centre Heerlen and VieCuri Medical Centre
Venlo/Venray. Primary outcome measure is treatment
success, defined as the proportion of participants with
≥ 75% reduction of the number of AK lesions in the
treatment area at 12 months post final treatment compared
to baseline. Secondary outcome is treatment success
at 3 months post final treatment, cost-effectiveness, side
effects, patient satisfaction, cosmetic outcome and treatment
compliance.