Clinical trial NCT05202860: Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients with Actinic Keratosis
Official title: Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients with Actinic Keratosis - a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Actinic Keratoses
Basal Cell Carcinoma
Squamous Cell Carcinoma
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 potential1 must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment and be on effective contraception2 until discontinuation of the vaccine therapy. Additional pregnancy testing will not be conducted unless pregnancy is suspected.

1Female 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.

2Intrauterine device or hormonal contraception (oral, implant, patch, vaginal ring, injection).

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 immunosuppressive 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

Primary outcomes:
measure: Treatment response in HPV vaccinated versus control group
timeFrame: Evaluated at month 2, 6, 9, and 12
Secondary outcomes:
measure: New AK lesions
timeFrame: Evaluated at month 2, 6, 9, 12
measure: Partial (≥75%) clearance
timeFrame: Evaluated at month 12
measure: Complete (100%) clearance
timeFrame: Evaluated at month 12
measure: Side Effects
timeFrame: Evaluated over the course of 12 months
measure: New Keratinocyte Carcinomas (KCs)
timeFrame: Evaluated at month 2, 6, 9, and 12
measure: Long term Keratinocyte Carcinoma (KC) rates
timeFrame: 10 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Dermatology, Bispebjerg Hospital
state: Hovedstaden
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Haedersdal, MD, PhD, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Emily Wenande, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: