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Topical Ionic Contra-Viral Therapy in Actinic Keratosis | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Topical Ionic Contra-Viral Therapy in Actinic Keratosis

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

NCT03684772•Maruho Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Locations (1)

Centre for Human Drug Research

Leiden, Netherlands

Key Dates

Start Date

October 22, 2018

Primary Completion Date

September 1, 2019

Completion Date

September 1, 2019

Last Updated

May 1, 2019

Enrollment

ESTIMATED participants

Conditions

Actinic Keratosis

Interventions

ICVT Topical Gel

DRUG

Furosemide Topical Gel

DRUG

Digoxin Topical Gel

DRUG

Vehicle Topical Gel

DRUG

Contacts

Robert Rissmann, PhD

CONTACT

+ 31 71 5246 400 clintrials@chdr.nl

The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans

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Actinic KeratosisImipramine+1 more

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RECRUITING

Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 1, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Topical Ionic Contra-Viral Therapy in Actinic Keratosis

Inclusion Criteria

Exclusion Criteria

The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans

Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns

The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

Trial to Investigate GZ21T in Healthy Volunteers

Indoor Daylight Photodynamic Therapy is an Effective, First-line Treatment for AK, But Its Feasibility is Limited by the Time Required for the Illumination (2 Hours). Our Objective Was to Evaluate the Efficacy of Idl-PDT With an Illumination Time of 1 Hour Versus 2 Hours in the Treatment of Scalp AK

Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis