Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients with Actinic Keratosis

NCT05202860 ↗

Phase 2 Active not recruiting 70 enrolled Merete Haedersdal

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A double-blind, randomized, placebo controlled intervention trial on patients with actinic keratosis.

Timeline

Start: 2022-05-09
Primary completion: 2024-06-19
Completion: 2034-06-19

Outcome

Mixed primary results

paper The preselected primary outcome was the percentage reduction in baseline AKs assessed 2, 6, 9, and 12 months after first vaccination. PMID 40047786 ↗

paper month 2: 35% [25%-44%] vs 25% [18%-33%]; P = .03; month 6: 47% [33%-53%] vs 29% [16%-44%]; P = .01 PMID 40047786 ↗

paper month 9: 58% [37%-63%] vs 42% [33%-56%]; P = .09; month 12: 58% [47%-69%] vs 47% [32%-65%]; P = .05 PMID 40047786 ↗

Publications

Wenande E, Hastrup A, Wiegell S, Philipsen PA, Thomsen NB, Demehri S, Kjaer SK, Haedersdal M. Human Papillomavirus Vaccination and Actinic Keratosis Burden: The VAXAK Randomized Clinical Trial. JAMA Dermatol. 2025 Jun 1;161(6):605-614. doi: 10.1001/jamadermatol.2025.0531.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gardasil 9	Vaccine	—	Intramuscular