Actinic KeratosisPhase 2NCT03684772
Topical Ionic Contra-Viral Therapy in Actinic Keratosis
A Phase 2 study testing ICVT Topical Gel, Furosemide Topical Gel and Digoxin Topical Gel in people with Actinic Keratosis, run by Maruho Co., Ltd. at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- ICVT Topical Gel, Furosemide Topical Gel and Digoxin Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Oct 2018to Sep 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Centre for Human Drug Research
Leiden
Robert Rissmann, PhD, + 31 (0)71 5246400, clintrials@chdr.nl
Robert Rissmann, PhD
About this study
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
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.
- Conditions
- Actinic Keratosis
- Being tested
- ICVT Topical Gel, Furosemide Topical Gel, Digoxin Topical Gel, Vehicle Topical Gel
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICVT Topical GelDrug
Digoxin and Furosemide (0.125%)
Furosemide Topical GelDrug
Furosemide (0.125%)
Digoxin Topical GelDrug
Digoxin (0.125%)
Vehicle Topical GelDrug
Vehicle Gel
| Study group | Role | What they receive |
|---|---|---|
| ICVT | Experimental | Digoxin and Furosemide (0.125%) Receives: Drug: ICVT Topical Gel |
| Furosemide | Experimental | Furosemide (0.125%) Receives: Drug: Furosemide Topical Gel |
| Digoxin | Experimental | Digoxin (0.125%) Receives: Drug: Digoxin Topical Gel |
| Placebo | Placebo comparator | Vehicle Gel Receives: Drug: Vehicle Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clinical clearance (CCC) per field
Measured: Day 42
Change in AK-FAS (AK field assessment scale)
AK Grade 0-IV, the higher the number the more % area covered by AK
Measured: Day 42
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
Measured: Day 126
Evolution of one assigned target lesion in the field, assessed by dermoscopy
assessing erythema, scaling, pigmentation, and follicular plug
Measured: Day 126
Field morphology
Change in lesion count per field
Measured: Day 126
Standardized photography with Canfield VISIA or 2D photography and with Antera 3D camera
Measured: Day 126
Biopsy biomarker
Analysis will be prerformed for the following biomarker: IFN-a. IFN-g, Ki-67
Measured: Day 126
Biopsy biomarker
Analysis will be prerformed for the following biomarker: IFN-g
Measured: Day 126
Biopsy biomarker
Analysis will be prerformed for the following biomarker: Ki-67
Measured: Day 126
Biopsy biomarker
Analysis will be prerformed for the following biomarker: p53
Measured: Day 126
Biopsy biomarker
Analysis will be prerformed for the following biomarker: MCM7(minichromosome maintenance protein 7)
Measured: Day 126
Biopsy biomarker
Analysis will be prerformed for the following biomarker:putrescene
Measured: Day 126
Biopsy biomarker
Analysis will be prerformed for the following biomarker: spermidine
Measured: Day 126
Biopsy biomarker
Analysis will be prerformed for the following biomarker: beta HPV types 5,8,15,20,24,38
Measured: Day 126
Skin swab markers
Swab analysis will be performed for beta HPV types 5,8,15,20,24,38.
Measured: Day 126
Secondary outcomes (12)
Adverse events collected throughout the study
Measured: Day 126
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: Heart Rate (bpm
Measured: Day 126
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: PR
Measured: Day 126
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: QRS
Measured: Day 126
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: QT
Measured: Day 126
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: QTcB
Measured: Day 126
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: QTcF
Measured: Day 126
Vital Signs performed at Screening and End of Study
The following will be assessed: Pulse Rate (bpm)
Measured: Day 42
Vital Signs performed at Screening and End of Study
The following will be assessed: Systolic blood pressure (mmHg)
Measured: Day 42
Vital Signs performed at Screening and End of Study
The following will be assessed: Diastolic blood pressure (mmHg)
Measured: Day 42
Vital Signs performed at Screening and End of Study
The following will be assessed: Temperature ( ̊ C)
Measured: Day 42
Patient diary on treatment application compliance, local tolerance and selfies photo
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start22 Oct 2018
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maruho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Rissmann, PhD, Principal investigator, Centre for Human Drug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684772
- Sponsor's protocol ID
- CLS003-CO-PR-004
- Status last verified
- Apr 2019
- First submitted
- 23 Aug 2018
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03684772
- Acronym / sponsor ID
- CLS003-CO-PR-004
- Conditions
- Actinic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ICVT | Experimental | Drug: ICVT Topical GelDigoxin and Furosemide (0.125%) |
| Furosemide | Experimental | Drug: Furosemide Topical GelFurosemide (0.125%) |
| Digoxin | Experimental | Drug: Digoxin Topical GelDigoxin (0.125%) |
| Placebo | Placebo comparator | Drug: Vehicle Topical GelVehicle Gel |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICVT Topical GelDigoxin and Furosemide (0.125%) | Drug | ICVT |
| Furosemide Topical GelFurosemide (0.125%) | Drug | Furosemide |
| Digoxin Topical GelDigoxin (0.125%) | Drug | Digoxin |
| Vehicle Topical GelVehicle Gel | Drug | Placebo |
Primary outcome
Complete clinical clearance (CCC) per field
Time frame: 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
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
Evolution of one assigned target lesion in the field, assessed by dermoscopy
Time frame: Day 126
assessing erythema, scaling, pigmentation, and follicular plug
Field morphology
Time frame: Day 126
Change in lesion count per field
Standardized photography with Canfield VISIA or 2D photography and with Antera 3D camera
Time frame: Day 126
Biopsy biomarker
Time frame: Day 126
Analysis will be prerformed for the following biomarker: IFN-a. IFN-g, Ki-67
Biopsy biomarker
Time frame: Day 126
Analysis will be prerformed for the following biomarker: IFN-g
Biopsy biomarker
Time frame: Day 126
Analysis will be prerformed for the following biomarker: Ki-67
Biopsy biomarker
Time frame: Day 126
Analysis will be prerformed for the following biomarker: p53
Biopsy biomarker
Time frame: Day 126
Analysis will be prerformed for the following biomarker: MCM7(minichromosome maintenance protein 7)
Biopsy biomarker
Time frame: Day 126
Analysis will be prerformed for the following biomarker:putrescene
Biopsy biomarker
Time frame: Day 126
Analysis will be prerformed for the following biomarker: spermidine
Biopsy biomarker
Time frame: Day 126
Analysis will be prerformed for the following biomarker: beta HPV types 5,8,15,20,24,38
Skin swab markers
Time frame: Day 126
Swab analysis will be performed for beta HPV types 5,8,15,20,24,38.
12 secondary outcomes
Adverse events collected throughout the study
Time frame: Day 126
12-Lead ECGs performed at Screening and End of Study
Time frame: Day 126
12-Lead ECGs performed at Screening and End of Study
Time frame: Day 126
12-Lead ECGs performed at Screening and End of Study
Time frame: Day 126
12-Lead ECGs performed at Screening and End of Study
Time frame: Day 126
12-Lead ECGs performed at Screening and End of Study
Time frame: Day 126
12-Lead ECGs performed at Screening and End of Study
Time frame: Day 126
Vital Signs performed at Screening and End of Study
Time frame: Day 42
Vital Signs performed at Screening and End of Study
Time frame: Day 42
Vital Signs performed at Screening and End of Study
Time frame: Day 42
Vital Signs performed at Screening and End of Study
Time frame: Day 42
Patient diary on treatment application compliance, local tolerance and selfies photo
Time frame: Day 42
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Rissmann, PhD principal investigator
Centre for Human Drug Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ICVT Topical Gel, Furosemide Topical Gel and Digoxin Topical Gel in people with Actinic Keratosis, run by Maruho Co., Ltd. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Rissmann, PhD (+ 31 71 5246 400, clintrials@chdr.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete clinical clearance (CCC) per field (time frame: Day 42). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.