A Phase 2, Randomized, Double Blind, Vehicle Controlled, Parallel Group Study to Explore the Efficacy, Pharmacodynamics and Safety of Topical Ionic Contra-Viral Therapy (ICVT) Comprised of Digoxin and Furosemide in Actinic Keratosis
试验速览
- 阶段
- 2 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Investigator global score (IGS) of each field
研究概览
简要总结
To explore the pharmacodynamics and evaluate safety, tolerability and clinical efficacy of ICVT comprised of digoxin and furosemide (dual agent), digoxin (single agent), furosemide (single agent) in patients with AK.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female subjects 18 years or older with verified condition of general good health (with exception of AK)
- •Confirmed clinical AK diagnosis by dermatologist
- •Subjects must have at least 2 facial fields of at least 25 cm² (but preferably >35 cm²) present at screening and baseline visit where more than 2 AK lesions are visible in each field (preferably the forehead, temple or cheek)
- •Subjects must be able to participate and willing to give written informed consent and to comply with the study restrictions
- •Subjects must be able to communicate well with the investigator in Dutch
- •Subjects willing to refrain from using other topical products in the treatment area, or prohibited medication for the duration of the study
- •Subjects must be willing to limit sun exposure of the involved skin to the extent vocationally possible
- •Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.
排除标准
- •Have used or received any treatment for AK in the treatment area within 28 days prior to enrollment (including topical medications, immunosuppressive or immunomodulating agents, phototherapy, oral retinoids, or other therapies for AKs)
- •Have any current pathologically relevant skin conditions in the field area other than AK (e.g. squamous cell carcinoma or basal cell carcinoma).
- •Have a known hypersensitivity to any of the investigational product ingredients, including digoxin and furosemide.
- •Current use of systemic digoxin or furosemide.
- •Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year
- •Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening or intention to donate blood or blood products during the study.
- •If a woman of childbearing potential, pregnant, or breast-feeding, or planning to become pregnant during the study.
研究组 & 干预措施
ICVT
Digoxin and Furosemide (0.125%)
干预措施: ICVT Topical Gel (Drug)
Furosemide
Furosemide (0.125%)
干预措施: Furosemide Topical Gel (Drug)
Digoxin
Digoxin (0.125%)
干预措施: Digoxin Topical Gel (Drug)
Placebo
Vehicle Gel
干预措施: Vehicle Topical Gel (Drug)
结局指标
主要结局
Investigator global score (IGS) of each field
时间窗: Day 126
This is a 7 point scale from -2 (significantly worse) to +4 (completely cured), higher values represent a better outcome
Complete clinical clearance (CCC) per field
时间窗: Day 42
Change in AK-FAS (AK field assessment scale)
时间窗: Day 42
AK Grade 0-IV, the higher the number the more % area covered by AK
Evolution of one assigned target lesion in the field, assessed by dermoscopy
时间窗: Day 126
assessing erythema, scaling, pigmentation, and follicular plug
Field morphology
时间窗: Day 126
Change in lesion count per field
Standardized photography with Canfield VISIA or 2D photography and with Antera 3D camera
时间窗: Day 126
Biopsy biomarker
时间窗: Day 126
Analysis will be prerformed for the following biomarker: beta HPV types 5,8,15,20,24,38
Skin swab markers
时间窗: Day 126
Swab analysis will be performed for beta HPV types 5,8,15,20,24,38.
次要结局
- Adverse events collected throughout the study(Day 126)
- 12-Lead ECGs performed at Screening and End of Study(Day 126)
- Vital Signs performed at Screening and End of Study(Day 42)
- Patient diary on treatment application compliance, local tolerance and selfies photo(Day 42)