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

Cutanea Life Sciences0 sites32 target enrollmentJuly 4, 2018

Overview

No summary available.

Registry

who.int

Start Date

July 4, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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.