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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Centre for Human Drug Research
Leiden, Netherlands
RECRUITINGComplete clinical clearance (CCC) per field
Time frame: Day 42
Change in AK-FAS (AK field assessment scale)
AK Grade 0-IV, the higher the number the more % area covered by AK
Time frame: 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
Time frame: Day 126
Evolution of one assigned target lesion in the field, assessed by dermoscopy
assessing erythema, scaling, pigmentation, and follicular plug
Time frame: Day 126
Field morphology
Change in lesion count per field
Time frame: Day 126
Standardized photography with Canfield VISIA or 2D photography and with Antera 3D camera
Time frame: Day 126
Biopsy biomarker
Analysis will be prerformed for the following biomarker: IFN-a. IFN-g, Ki-67
Time frame: Day 126
Biopsy biomarker
Analysis will be prerformed for the following biomarker: IFN-g
Time frame: Day 126
Biopsy biomarker
Analysis will be prerformed for the following biomarker: Ki-67
Time frame: Day 126
Biopsy biomarker
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Vehicle Gel
Analysis will be prerformed for the following biomarker: p53
Time frame: Day 126
Biopsy biomarker
Analysis will be prerformed for the following biomarker: MCM7(minichromosome maintenance protein 7)
Time frame: Day 126
Biopsy biomarker
Analysis will be prerformed for the following biomarker:putrescene
Time frame: Day 126
Biopsy biomarker
Analysis will be prerformed for the following biomarker: spermidine
Time frame: Day 126
Biopsy biomarker
Analysis will be prerformed for the following biomarker: beta HPV types 5,8,15,20,24,38
Time frame: Day 126
Skin swab markers
Swab analysis will be performed for beta HPV types 5,8,15,20,24,38.
Time frame: Day 126
Adverse events collected throughout the study
Time frame: Day 126
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: Heart Rate (bpm
Time frame: Day 126
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: PR
Time frame: Day 126
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: QRS
Time frame: Day 126
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: QT
Time frame: Day 126
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: QTcB
Time frame: Day 126
12-Lead ECGs performed at Screening and End of Study
The following component will be assessed: QTcF
Time frame: Day 126
Vital Signs performed at Screening and End of Study
The following will be assessed: Pulse Rate (bpm)
Time frame: Day 42
Vital Signs performed at Screening and End of Study
The following will be assessed: Systolic blood pressure (mmHg)
Time frame: Day 42
Vital Signs performed at Screening and End of Study
The following will be assessed: Diastolic blood pressure (mmHg)
Time frame: Day 42
Vital Signs performed at Screening and End of Study
The following will be assessed: Temperature ( ̊ C)
Time frame: Day 42
Patient diary on treatment application compliance, local tolerance and selfies photo
Time frame: Day 42