Topical Ionic Contra-Viral Therapy in Actinic Keratosis

April 29, 2019 updated by: Maruho Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Leiden, Netherlands
        • Recruiting
        • Centre For Human Drug Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: ICVT
Digoxin and Furosemide (0.125%)
Drug: ICVT Topical Gel
Digoxin and Furosemide (0.125%)
EXPERIMENTAL: Furosemide
Furosemide (0.125%)
Drug: Furosemide Topical Gel
Furosemide (0.125%)
EXPERIMENTAL: Digoxin
Digoxin (0.125%)
Drug: Digoxin Topical Gel
Digoxin (0.125%)
PLACEBO_COMPARATOR: Placebo
Vehicle Gel
Drug: Vehicle Topical Gel
Vehicle Gel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete clinical clearance (CCC) per field
Time Frame: Day 42
Day 42
Change in AK-FAS (AK field assessment scale)
Time Frame: Day 42
AK Grade 0-IV, the higher the number the more % area covered by AK
Day 42
Investigator global score (IGS) of each field
Time Frame: Day 126
This is a 7 point scale from -2 (significantly worse) to +4 (completely cured), higher values represent a better outcome
Day 126
Evolution of one assigned target lesion in the field, assessed by dermoscopy
Time Frame: Day 126
assessing erythema, scaling, pigmentation, and follicular plug
Day 126
Field morphology
Time Frame: Day 126
Change in lesion count per field
Day 126
Standardized photography with Canfield VISIA or 2D photography and with Antera 3D camera
Time Frame: Day 126
Day 126
Biopsy biomarker
Time Frame: Day 126
Analysis will be prerformed for the following biomarker: IFN-a. IFN-g, Ki-67
Day 126
Biopsy biomarker
Time Frame: Day 126
Analysis will be prerformed for the following biomarker: IFN-g
Day 126
Biopsy biomarker
Time Frame: Day 126
Analysis will be prerformed for the following biomarker: Ki-67
Day 126
Biopsy biomarker
Time Frame: Day 126
Analysis will be prerformed for the following biomarker: p53
Day 126
Biopsy biomarker
Time Frame: Day 126
Analysis will be prerformed for the following biomarker: MCM7(minichromosome maintenance protein 7)
Day 126
Biopsy biomarker
Time Frame: Day 126
Analysis will be prerformed for the following biomarker:putrescene
Day 126
Biopsy biomarker
Time Frame: Day 126
Analysis will be prerformed for the following biomarker: spermidine
Day 126
Biopsy biomarker
Time Frame: Day 126
Analysis will be prerformed for the following biomarker: beta HPV types 5,8,15,20,24,38
Day 126
Skin swab markers
Time Frame: Day 126
Swab analysis will be performed for beta HPV types 5,8,15,20,24,38.
Day 126

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events collected throughout the study
Time Frame: Day 126
Day 126
12-Lead ECGs performed at Screening and End of Study
Time Frame: Day 126
The following component will be assessed: Heart Rate (bpm
Day 126
12-Lead ECGs performed at Screening and End of Study
Time Frame: Day 126
The following component will be assessed: PR
Day 126
12-Lead ECGs performed at Screening and End of Study
Time Frame: Day 126
The following component will be assessed: QRS
Day 126
12-Lead ECGs performed at Screening and End of Study
Time Frame: Day 126
The following component will be assessed: QT
Day 126
12-Lead ECGs performed at Screening and End of Study
Time Frame: Day 126
The following component will be assessed: QTcB
Day 126
12-Lead ECGs performed at Screening and End of Study
Time Frame: Day 126
The following component will be assessed: QTcF
Day 126
Vital Signs performed at Screening and End of Study
Time Frame: Day 42
The following will be assessed: Pulse Rate (bpm)
Day 42
Vital Signs performed at Screening and End of Study
Time Frame: Day 42
The following will be assessed: Systolic blood pressure (mmHg)
Day 42
Vital Signs performed at Screening and End of Study
Time Frame: Day 42
The following will be assessed: Diastolic blood pressure (mmHg)
Day 42
Vital Signs performed at Screening and End of Study
Time Frame: Day 42
The following will be assessed: Temperature ( ̊ C)
Day 42
Patient diary on treatment application compliance, local tolerance and selfies photo
Time Frame: Day 42
Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maruho Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLS003-CO-PR-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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