Squamous Cell Carcinoma Clinical Trial
Official title:
Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients With Actinic Keratosis - a Double-blind Randomized Controlled Trial
A double-blind, randomized, placebo controlled intervention trial on patients with actinic keratosis.
Endeavoring to develop a new therapeutic and preventative strategy for patients with AK, this study aims to investigate the impact of 9-valent HPV vaccination on AK burden and -development over the course of 12 months. Seventy actinic keratosis (AK) patients are randomized 1:1 to two parallel groups that receive blinded HPV vaccination or sham placebo (isotonic NaCl) vaccination at baseline (day 0), month 2 and month 6. At month 6 and 9, both groups undergo lesion-directed cryotherapy of Olsen grade II-III AKs. Treatment response, based on percentage change (%) in baseline number of AK lesions in a predefined test area (primary outcome), is evaluated at months 2, 6, 9, and 12. ;
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