Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients with Actinic Keratosis - a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Treatment response in HPV vaccinated versus control group
研究概览
简要总结
A double-blind, randomized, placebo controlled intervention trial on patients with actinic keratosis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
HPV vaccine
Commercially available nonavalent HPV vaccine (Gardasil(R) 9) given intramuscularly at baseline, month 2 and month 6
干预措施: HPV Vaccine (Biological)
Isotonic Saltwater Vaccine
0.9% NaCl given intramuscularly at baseline, month 2 and month 6
干预措施: PLACEBO vaccine (Biological)
结局指标
主要结局
Treatment response in HPV vaccinated versus control group
时间窗: Evaluated at month 2, 6, 9, and 12
Percentage change from baseline (%) in number of AK lesions (grades I and II-III) in the selected test area
次要结局
- New AK lesions(Evaluated at month 2, 6, 9, 12)
- Partial (≥75%) clearance(Evaluated at month 12)
- Complete (100%) clearance(Evaluated at month 12)
- Side Effects(Evaluated over the course of 12 months)
- New Keratinocyte Carcinomas (KCs)(Evaluated at month 2, 6, 9, and 12)
- Long term Keratinocyte Carcinoma (KC) rates(10 years)
研究者
Merete Haedersdal
Sponsor-Investigator
Bispebjerg Hospital