Back to resultsTopical Ionic Contra-Viral Therapy in Actinic Keratosis
Primary Purpose
Actinic Keratosis
Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
ICVT Topical Gel
Furosemide Topical Gel
Digoxin Topical Gel
Vehicle Topical Gel
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis
Eligibility Criteria
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.
Sites / Locations
- Centre for Human Drug ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
ICVT
Furosemide
Digoxin
Placebo
Arm Description
Digoxin and Furosemide (0.125%)
Furosemide (0.125%)
Digoxin (0.125%)
Vehicle Gel
Outcomes
Primary Outcome Measures
Complete clinical clearance (CCC) per field
Change in AK-FAS (AK field assessment scale)
AK Grade 0-IV, the higher the number the more % area covered by AK
Investigator global score (IGS) of each field
This is a 7 point scale from -2 (significantly worse) to +4 (completely cured), higher values represent a better outcome
Evolution of one assigned target lesion in the field, assessed by dermoscopy
assessing erythema, scaling, pigmentation, and follicular plug
Field morphology
Change in lesion count per field
Standardized photography with Canfield VISIA or 2D photography and with Antera 3D camera
Biopsy biomarker
Analysis will be prerformed for the following biomarker: IFN-a. IFN-g, Ki-67
Biopsy biomarker
Analysis will be prerformed for the following biomarker: IFN-g
Biopsy biomarker
Analysis will be prerformed for the following biomarker: Ki-67
Biopsy biomarker
Analysis will be prerformed for the following biomarker: p53
Biopsy biomarker
Analysis will be prerformed for the following biomarker: MCM7(minichromosome maintenance protein 7)
Biopsy biomarker
Analysis will be prerformed for the following biomarker:putrescene
Biopsy biomarker
Analysis will be prerformed for the following biomarker: spermidine
Biopsy biomarker
Analysis will be prerformed for the following biomarker: beta HPV types 5,8,15,20,24,38
Skin swab markers
Swab analysis will be performed for beta HPV types 5,8,15,20,24,38.
Secondary Outcome Measures
Adverse events collected throughout the study
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: Heart Rate (bpm
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: PR
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: QRS
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: QT
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: QTcB
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: QTcF
Vital Signs performed at Screening and End of Study
The following will be assessed: Pulse Rate (bpm)
Vital Signs performed at Screening and End of Study
The following will be assessed: Systolic blood pressure (mmHg)
Vital Signs performed at Screening and End of Study
The following will be assessed: Diastolic blood pressure (mmHg)
Vital Signs performed at Screening and End of Study
The following will be assessed: Temperature ( ̊ C)
Patient diary on treatment application compliance, local tolerance and selfies photo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03684772
Brief Title
Topical Ionic Contra-Viral Therapy in Actinic Keratosis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maruho Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICVT
Arm Type
Experimental
Arm Description
Digoxin and Furosemide (0.125%)
Arm Title
Furosemide
Arm Type
Experimental
Arm Description
Furosemide (0.125%)
Arm Title
Digoxin
Arm Type
Experimental
Arm Description
Digoxin (0.125%)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vehicle Gel
Intervention Type
Drug
Intervention Name(s)
ICVT Topical Gel
Intervention Description
Digoxin and Furosemide (0.125%)
Intervention Type
Drug
Intervention Name(s)
Furosemide Topical Gel
Intervention Description
Furosemide (0.125%)
Intervention Type
Drug
Intervention Name(s)
Digoxin Topical Gel
Intervention Description
Digoxin (0.125%)
Intervention Type
Drug
Intervention Name(s)
Vehicle Topical Gel
Intervention Description
Vehicle Gel
Primary Outcome Measure Information:
Title
Complete clinical clearance (CCC) per field
Time Frame
Day 42
Title
Change in AK-FAS (AK field assessment scale)
Description
AK Grade 0-IV, the higher the number the more % area covered by AK
Time Frame
Day 42
Title
Investigator global score (IGS) of each field
Description
This is a 7 point scale from -2 (significantly worse) to +4 (completely cured), higher values represent a better outcome
Time Frame
Day 126
Title
Evolution of one assigned target lesion in the field, assessed by dermoscopy
Description
assessing erythema, scaling, pigmentation, and follicular plug
Time Frame
Day 126
Title
Field morphology
Description
Change in lesion count per field
Time Frame
Day 126
Title
Standardized photography with Canfield VISIA or 2D photography and with Antera 3D camera
Time Frame
Day 126
Title
Biopsy biomarker
Description
Analysis will be prerformed for the following biomarker: IFN-a. IFN-g, Ki-67
Time Frame
Day 126
Title
Biopsy biomarker
Description
Analysis will be prerformed for the following biomarker: IFN-g
Time Frame
Day 126
Title
Biopsy biomarker
Description
Analysis will be prerformed for the following biomarker: Ki-67
Time Frame
Day 126
Title
Biopsy biomarker
Description
Analysis will be prerformed for the following biomarker: p53
Time Frame
Day 126
Title
Biopsy biomarker
Description
Analysis will be prerformed for the following biomarker: MCM7(minichromosome maintenance protein 7)
Time Frame
Day 126
Title
Biopsy biomarker
Description
Analysis will be prerformed for the following biomarker:putrescene
Time Frame
Day 126
Title
Biopsy biomarker
Description
Analysis will be prerformed for the following biomarker: spermidine
Time Frame
Day 126
Title
Biopsy biomarker
Description
Analysis will be prerformed for the following biomarker: beta HPV types 5,8,15,20,24,38
Time Frame
Day 126
Title
Skin swab markers
Description
Swab analysis will be performed for beta HPV types 5,8,15,20,24,38.
Time Frame
Day 126
Secondary Outcome Measure Information:
Title
Adverse events collected throughout the study
Time Frame
Day 126
Title
12-Lead ECGs performed at Screening and End of Study
Description
The following component will be assessed: Heart Rate (bpm
Time Frame
Day 126
Title
12-Lead ECGs performed at Screening and End of Study
Description
The following component will be assessed: PR
Time Frame
Day 126
Title
12-Lead ECGs performed at Screening and End of Study
Description
The following component will be assessed: QRS
Time Frame
Day 126
Title
12-Lead ECGs performed at Screening and End of Study
Description
The following component will be assessed: QT
Time Frame
Day 126
Title
12-Lead ECGs performed at Screening and End of Study
Description
The following component will be assessed: QTcB
Time Frame
Day 126
Title
12-Lead ECGs performed at Screening and End of Study
Description
The following component will be assessed: QTcF
Time Frame
Day 126
Title
Vital Signs performed at Screening and End of Study
Description
The following will be assessed: Pulse Rate (bpm)
Time Frame
Day 42
Title
Vital Signs performed at Screening and End of Study
Description
The following will be assessed: Systolic blood pressure (mmHg)
Time Frame
Day 42
Title
Vital Signs performed at Screening and End of Study
Description
The following will be assessed: Diastolic blood pressure (mmHg)
Time Frame
Day 42
Title
Vital Signs performed at Screening and End of Study
Description
The following will be assessed: Temperature ( ̊ C)
Time Frame
Day 42
Title
Patient diary on treatment application compliance, local tolerance and selfies photo
Time Frame
Day 42
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Rissmann, PhD
Phone
+ 31 71 5246 400
Email
clintrials@chdr.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Rissmann, PhD
Organizational Affiliation
Centre for Human Drug Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Human Drug Research
City
Leiden
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Rissmann, PhD
Phone
+ 31 (0)71 5246400
Email
clintrials@chdr.nl
First Name & Middle Initial & Last Name & Degree
Robert Rissmann, PhD
12. IPD Sharing Statement
Learn more about this trial
Topical Ionic Contra-Viral Therapy in Actinic Keratosis
We'll reach out to this number within 24 hrs