NL-OMON48691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 keratosis - Topical ionic contra-viral therapy in actinic keratosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
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 at least 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
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
- •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
进行中（未招募）
1 期
Topical ionic contra-viral therapy in actinic keratosisActinic keratosisMedDRA version: 20.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2018-000034-36-NLCutanea Life Sciences32
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