Human Papillomavirus Vaccination and Actinic Keratosis Burden
Clinical Summary
View sourceWhat was studied
A single-center, parallel, double-blind, randomized sham-controlled trial in Denmark tested whether a 9-valent alphapapillomavirus vaccine reduced actinic keratosis (AK) burden over 12 months in immunocompetent adults with ≥15 AKs in a 50–100 cm2 test area versus saline injections. Vaccinations were given at 0, 2, and 6 months; thick AKs received cryotherapy at months 6 and 9; the primary outcome was percent reduction from baseline AKs at 2, 6, 9, and 12 months.
Key findings
Median AK reduction was greater with HPV vaccine vs sham at month 2 (35% vs 25%; P=.03), month 6 (47% vs 29%; P=.01), month 9 (58% vs 42%; P=.09), and month 12 (58% vs 47%; P=.05). Total AK counts and thick AKs were lower at months 6 and 12 with vaccination, while rates of new AKs (1–2 per month) and keratinocyte carcinomas did not differ over 12 months.
Study limitations
Single-center trial with n=70 and 12-month follow-up limits generalizability and long-term inference. Cryotherapy was administered to thick lesions at months 6 and 9 in both arms, which may affect interpretation of lesion counts after mid-trial.
Clinical implications
In immunocompetent patients with numerous AKs, 9-valent HPV vaccination reduced existing AK burden over 12 months versus sham, but did not lower new AK formation or keratinocyte carcinomas. Use these findings as emerging evidence when counseling patients about AK management options.
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