Actinic Keratosis
Conditions
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.
Interventions
DRUGICVT Topical Gel
Digoxin and Furosemide (0.125%)
DRUGFurosemide Topical Gel
Furosemide (0.125%)
DRUGDigoxin Topical Gel
Digoxin (0.125%)
Vehicle Gel
Sponsors
Maruho Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin swab markers | Day 126 | Swab analysis will be performed for beta HPV types 5,8,15,20,24,38. |
| Evolution of one assigned target lesion in the field, assessed by dermoscopy | Day 126 | assessing erythema, scaling, pigmentation, and follicular plug |
| Field morphology | Day 126 | Change in lesion count per field |
| Standardized photography with Canfield VISIA or 2D photography and with Antera 3D camera | Day 126 | — |
| Biopsy biomarker | Day 126 | Analysis will be prerformed for the following biomarker: IFN-a. IFN-g, Ki-67 |
| Complete clinical clearance (CCC) per field | Day 42 | — |
| Change in AK-FAS (AK field assessment scale) | Day 42 | AK Grade 0-IV, the higher the number the more % area covered by AK |
| Investigator global score (IGS) of each field | Day 126 | This is a 7 point scale from -2 (significantly worse) to +4 (completely cured), higher values represent a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12-Lead ECGs performed at Screening and End of Study | Day 126 | The following component will be assessed: Heart Rate (bpm |
| Vital Signs performed at Screening and End of Study | Day 42 | The following will be assessed: Pulse Rate (bpm) |
| Patient diary on treatment application compliance, local tolerance and selfies photo | Day 42 | — |
| Adverse events collected throughout the study | Day 126 | — |
Countries
Netherlands
Contacts
Primary ContactRobert Rissmann, PhD
Outcome results
None listed