- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03684772
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
Unknown
Conditions
Intervention / Treatment
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
- Name: Robert Rissmann, PhD
- Phone Number: + 31 71 5246 400
- Email: clintrials@chdr.nl
Study Locations
-
-
-
Leiden, Netherlands
- Recruiting
- Centre for Human Drug Research
-
Contact:
- Robert Rissmann, PhD
- Phone Number: + 31 (0)71 5246400
- Email: clintrials@chdr.nl
-
-
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.
Sponsor
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
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Precancerous Conditions
- Keratosis, Actinic
- Keratosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Enzyme Inhibitors
- Protective Agents
- Natriuretic Agents
- Cardiotonic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Potassium Chloride Symporter Inhibitors
- Digoxin
- Furosemide
Other Study ID 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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