Status:
ACTIVE_NOT_RECRUITING
Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients with Actinic Keratosis
Lead Sponsor:
Merete Haedersdal
Conditions:
Actinic Keratoses
Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 co...
Eligibility Criteria
Inclusion
- Subjects who meet all the following criteria are eligible to participate in this study:
- High AK burden, defined as ≥15 AK lesions in the included test area (50-100 cm2) at baseline
- Test area does not involve the ala nasi, eyelids, nasolabial folds, or periauricular skin
- \>18 years of age at baseline
- Fitzpatrick skin phototype I-IV
- Legally competent, able to give verbal and written informed consent
- 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.
- 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
- Subjects meeting any of the following criteria are not eligible to participate in this study:
- Known or suspected immunosuppression (by disease or immunosuppressive drug)
- History of vaccine-related allergic reactions or known allergy to Gardasil®9 ingredients or yeast
- Previously vaccinated with any HPV vaccine
- History of keloids
- Other skin diseases present in the test area at baseline
- Lactating or pregnant women
Key Trial Info
Start Date :
May 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2034
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05202860
Start Date
May 9 2022
End Date
June 19 2034
Last Update
January 22 2025
Active Locations (1)
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1
Department of Dermatology, Bispebjerg Hospital
Copenhagen, Capital Region, Denmark, 2400