Topical Ionic Contra-Viral Therapy in Actinic Keratosis

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Field morphology	Day 126	Change in lesion count per field
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
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
Evolution of one assigned target lesion in the field, assessed by dermoscopy	Day 126	assessing erythema, scaling, pigmentation, and follicular plug
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: beta HPV types 5,8,15,20,24,38
Skin swab markers	Day 126	Swab analysis will be performed for beta HPV types 5,8,15,20,24,38.

Secondary Outcome Measures

Name	Time	Method
Adverse events collected throughout the study	Day 126
12-Lead ECGs performed at Screening and End of Study	Day 126	The following component will be assessed: QTcF
Vital Signs performed at Screening and End of Study	Day 42	The following will be assessed: Temperature ( ̊ C)
Patient diary on treatment application compliance, local tolerance and selfies photo	Day 42

Recruitment & Eligibility