Human papillomavirus (HPV) vaccination for treatment of premalignant skin lesions

Phase 1

• Conditions: Actinic Keratosis (AK); MedDRA version: 20.0Level: HLTClassification code 10052567Term: Skin preneoplastic conditions NECSystem Organ Class: 100000004858; MedDRA version: 20.0Level: HLTClassification code 10040901Term: Skin neoplasms malignant and unspecified (excl melanoma)System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2021-003895-15-DK
• Lead Sponsor: Bispebjerg Hospital, Department of Dermatology and Venereology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-07
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Subjects who meet all the following criteria are eligible to participate in this study:
1.High AK burden, defined as =15 AK lesions in the included test area (50-100 cm2) at baseline
2.Test area does not involve the ala nasi, eyelids, nasolabial folds, or periauricular skin
3.>18 years of age at baseline
4.Fitzpatrick skin phototype I-IV
5.Legally competent, able to give verbal and written informed consent
6.Subject is willing to participate and can comply with protocol requirements including the refraining from other therapy (with the exception of KC treatment) in the test area for the duration of the trial.
7.Women of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment and be on effective contraception until discontinuation of the vaccine therapy. Additional pregnancy testing will not be conducted unless pregnancy is suspected.
(Female subjects are considered of childbearing potential unless they have been hysterectomized or have undergone tubal ligation or have been post-menopausal for at least one year prior to first visit. Effective contraception is IUD or hormonal contraception as specified in the protocol)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

Subjects meeting any of the following criteria are not eligible to participate in this study:
1.Known or suspected immunosuppression (by disease or immunosupressive drug)
2.History of vaccine-related allergic reactions or known allergy to Gardasil®9 ingredients or yeast
3.Previously vaccinated with any HPV vaccine
4.History of keloids
5.Other skin diseases present in the test area at baseline
6.Lactating or pregnant women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: To assess local and systemic side effects in HPV vaccinated versus control group over 12 months<br><br>To assess the impact of 9-valent HPV vaccination on new keratinocyte carcinoma development over 12 months;Primary end point(s): Primary outcome:<br>1)Treatment response in HPV vaccinated versus control group based on: <br>Percentage change from baseline (%) in number of AK lesions (grades I and II-III) in the selected test area <br><br><br>;Timepoint(s) of evaluation of this end point: Evaluated at month 2, 6, 9, and 12