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

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • 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 Locations

      • 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

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
Intervention / Treatment
EXPERIMENTAL: ICVT
Digoxin and Furosemide (0.125%)
Digoxin and Furosemide (0.125%)
EXPERIMENTAL: Furosemide
Furosemide (0.125%)
Furosemide (0.125%)
EXPERIMENTAL: Digoxin
Digoxin (0.125%)
Digoxin (0.125%)
PLACEBO_COMPARATOR: Placebo
Vehicle Gel
Vehicle Gel

What is the study measuring?

Primary Outcome Measures

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

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.

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)

October 22, 2018

Primary Completion (ANTICIPATED)

September 1, 2019

Study Completion (ANTICIPATED)

September 1, 2019

Study Registration Dates

First Submitted

August 23, 2018

First Submitted That Met QC Criteria

September 24, 2018

First Posted (ACTUAL)

September 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

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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