EUCTR2018-000034-36-NL进行中（未招募）1 期
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 healthy volunteers with actinic keratosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •For enrollment of subjects the following criteria must be met:
- •1.Male and female subjects =18 years with a condition of general good health (with the exception of AK). The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AK following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
- •2.Confirmed clinical AK diagnosis by dermatologist (biopsy proven after end of study, in untreated part of the AK field)
- •3.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)
- •4.Able to participate and willing to give written informed consent and to comply with the study restrictions.
- •5.Ability to communicate well with the investigator in Dutch.
- •6.Willing to refrain from using other topical products in the treatment area, or prohibited medications for the duration of the study.
- •7.Willing to limit sun exposure of the involved skin to the extent vocationally possible.
- •8.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.
- •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 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •Eligible subjects must meet none of the following exclusion criteria:
- •1.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)
- •2.Have any current pathologically relevant skin conditions in the field area other than AK (e.g. squamous cell carcinoma or basal cell carcinoma).
- •3.Have a known hypersensitivity to any of the investigational product ingredients, including digoxin and furosemide.
- •4.Current use of systemic digoxin or furosemide.
- •5.Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year
- •6.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.
- •7.If a woman of childbearing potential, pregnant, or breast-feeding, or planning to become pregnant during the study.
研究者
相似试验
已完成
2 期
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 keratosisActinic keratosis10014982NL-OMON48691Maruho Co., Ltd.32
进行中（未招募）
1 期
A Phase 2 Study Evaluating the Safety, Efficacy and Pharmacokinetics of Single Dose EP-104IAR for 24 Weeks in Patients with Osteoarthritis of the KneeOsteoarthritis of the kneeMedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859EUCTR2021-000859-39-DKEupraxia Pharmaceuticals Inc.300
招募中
1 期
Effects of a new topical treatment, Victorhy, in patients with severe hand hyperhidrosisCTIS2023-507114-27-00Dryox Health S.L.60
已完成
2 期
Evaluation of HXP124 in the treatment of a fungal nail infection, onychomycosis.Toenail OnychomycosisInfection - Other infectious diseasesSkin - Dermatological conditionsACTRN12620000697987Hexima Ltd117
进行中（未招募）
1 期
Digoxin / Furosemide topical therapy for genital warts and VIN lesions of immunocompromised and immunocompetent patientsEUCTR2016-000870-39-NLCutanea Life Sciences48