NCT05202860

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

Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients with Actinic Keratosis - a Double-blind Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Merete Haedersdal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Actinic Keratoses
• Basal Cell Carcinoma
• Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	HPV Vaccine	(Gardasil 9 human papilloma vaccine)
BIOLOGICAL	PLACEBO vaccine	Isotonic saltwater sham vaccine

Timeline

• Start date: 2022-05-09
• Primary completion: 2024-06-19
• Completion: 2034-06-19
• First posted: 2022-01-24
• Last updated: 2025-01-22

Locations

1 site across 1 country: Denmark