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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICVT | Experimental | Digoxin and Furosemide (0.125%) |
|
| Furosemide | Experimental | Furosemide (0.125%) |
|
| Digoxin | Experimental | Digoxin (0.125%) |
|
| Placebo | Placebo Comparator | Vehicle Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICVT Topical Gel | Drug | Digoxin and Furosemide (0.125%) |
| |
| Furosemide Topical Gel |
| Measure | Description | Time Frame |
|---|---|---|
| Complete clinical clearance (CCC) per field | Day 42 | |
| Change in AK-FAS (AK field assessment scale) | AK Grade 0-IV, the higher the number the more % area covered by AK | 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 | Day 126 |
| Evolution of one assigned target lesion in the field, assessed by dermoscopy | assessing erythema, scaling, pigmentation, and follicular plug | Day 126 |
| Field morphology | Change in lesion count per field | Day 126 |
| Standardized photography with Canfield VISIA or 2D photography and with Antera 3D camera | Day 126 | |
| Biopsy biomarker | Analysis will be prerformed for the following biomarker: IFN-a. IFN-g, Ki-67 | Day 126 |
| Biopsy biomarker | Analysis will be prerformed for the following biomarker: IFN-g | Day 126 |
| Biopsy biomarker |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events collected throughout the study | Day 126 | |
| 12-Lead ECGs performed at Screening and End of Study | The following component will be assessed: Heart Rate (bpm | Day 126 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Rissmann, PhD | Contact | + 31 71 5246 400 | clintrials@chdr.nl |
| Name | Affiliation | Role |
|---|---|---|
| Robert Rissmann, PhD | Centre for Human Drug Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Human Drug Research | Recruiting | Leiden | Netherlands |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| Drug |
Furosemide (0.125%) |
|
| Digoxin Topical Gel | Drug | Digoxin (0.125%) |
|
| Vehicle Topical Gel | Drug | Vehicle Gel |
|
Analysis will be prerformed for the following biomarker: Ki-67 |
| Day 126 |
| Biopsy biomarker | Analysis will be prerformed for the following biomarker: p53 | Day 126 |
| Biopsy biomarker | Analysis will be prerformed for the following biomarker: MCM7(minichromosome maintenance protein 7) | Day 126 |
| Biopsy biomarker | Analysis will be prerformed for the following biomarker:putrescene | Day 126 |
| Biopsy biomarker | Analysis will be prerformed for the following biomarker: spermidine | Day 126 |
| Biopsy biomarker | Analysis will be prerformed for the following biomarker: beta HPV types 5,8,15,20,24,38 | Day 126 |
| Skin swab markers | Swab analysis will be performed for beta HPV types 5,8,15,20,24,38. | Day 126 |
| 12-Lead ECGs performed at Screening and End of Study | The following component will be assessed: PR | Day 126 |
| 12-Lead ECGs performed at Screening and End of Study | The following component will be assessed: QRS | Day 126 |
| 12-Lead ECGs performed at Screening and End of Study | The following component will be assessed: QT | Day 126 |
| 12-Lead ECGs performed at Screening and End of Study | The following component will be assessed: QTcB | Day 126 |
| 12-Lead ECGs performed at Screening and End of Study | The following component will be assessed: QTcF | Day 126 |
| Vital Signs performed at Screening and End of Study | The following will be assessed: Pulse Rate (bpm) | Day 42 |
| Vital Signs performed at Screening and End of Study | The following will be assessed: Systolic blood pressure (mmHg) | Day 42 |
| Vital Signs performed at Screening and End of Study | The following will be assessed: Diastolic blood pressure (mmHg) | Day 42 |
| Vital Signs performed at Screening and End of Study | The following will be assessed: Temperature ( ĚŠ C) | Day 42 |
| Patient diary on treatment application compliance, local tolerance and selfies photo | Day 42 |
| D017437 |
| Skin and Connective Tissue Diseases |