Actinic Keratosis (AK) MedDRA version: 20.0 Level: HLT Classification code 10052567 Term: Skin preneoplastic conditions NEC System Organ Class: 100000004858 MedDRA version: 20.0 Level: HLT Classification code 10040901 Term: Skin neoplasms malignant and unspecified (excl melanoma) System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Gardasil® 9
Product Name: Gardasil® 9
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Gardasil® 9
Other descriptive name: HUMAN PAPILLOMAVIRUS VACC
Sponsors
Bispebjerg Hospital, Department of Dermatology and Venereology
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 To assess the impact of 9-valent HPV vaccination on new keratinocyte carcinoma development over 12 months;Primary end point(s): Primary outcome: 1)Treatment response in HPV vaccinated versus control group based on: Percentage change from baseline (%) in number of AK lesions (grades I and II-III) in the selected test area ;Timepoint(s) of evaluation of this end point: Evaluated at month 2, 6, 9, and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2) Treatment response in HPV vaccinated versus control group based on: I. New AK lesions (n) arising in the test area since last visit II. Partial (=75%) clearance: atleast 75 % reduction in total number of AK lesions compared to baseline III. Complete (100%) clearance: 100 % reduction in total number of AK lesions compared to baseline 3) Occurance of local and systemic side effects in HPV vaccinated versus control group 4) New Keratinocyte carcinoma (KC) anywhere on the skin surface in HPV vaccinated versus control group registered over the course of the 12-month trial, compared to average yearly KC rate (determined by medical record or pathology results) 3 years prior to baseline. ;Timepoint(s) of evaluation of this end point: 2) Treatment response in HPV vaccinated versus control group based on: I. Evaluated at month 2, 6, 9, 12 II. Evaluated at month 12 III. Evaluated at month 12 3) Over the course of the 12-month trial period 4) Over the course of the 12-month trial period | — |
Countries
Denmark
Contacts
Public ContactEmily Wenande
Bispebjerg Hospital, Department of Dermatology and Venereology
Outcome results
None listed