Clinical trial NCT03684772: Topical Ionic Contra-Viral Therapy in Actinic Keratosis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Actinic Keratosis
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Complete clinical clearance (CCC) per field
timeFrame: Day 42
measure: Change in AK-FAS (AK field assessment scale)
timeFrame: Day 42
measure: Investigator global score (IGS) of each field
timeFrame: Day 126
measure: Evolution of one assigned target lesion in the field, assessed by dermoscopy
timeFrame: Day 126
measure: Field morphology
timeFrame: Day 126
measure: Standardized photography with Canfield VISIA or 2D photography and with Antera 3D camera
timeFrame: Day 126
measure: Biopsy biomarker
timeFrame: Day 126
measure: Biopsy biomarker
timeFrame: Day 126
measure: Biopsy biomarker
timeFrame: Day 126
measure: Biopsy biomarker
timeFrame: Day 126
measure: Biopsy biomarker
timeFrame: Day 126
measure: Biopsy biomarker
timeFrame: Day 126
measure: Biopsy biomarker
timeFrame: Day 126
measure: Biopsy biomarker
timeFrame: Day 126
measure: Skin swab markers
timeFrame: Day 126
Secondary outcomes:
measure: Adverse events collected throughout the study
timeFrame: Day 126
measure: 12-Lead ECGs performed at Screening and End of Study
timeFrame: Day 126
measure: 12-Lead ECGs performed at Screening and End of Study
timeFrame: Day 126
measure: 12-Lead ECGs performed at Screening and End of Study
timeFrame: Day 126
measure: 12-Lead ECGs performed at Screening and End of Study
timeFrame: Day 126
measure: 12-Lead ECGs performed at Screening and End of Study
timeFrame: Day 126
measure: 12-Lead ECGs performed at Screening and End of Study
timeFrame: Day 126
measure: Vital Signs performed at Screening and End of Study
timeFrame: Day 42
measure: Vital Signs performed at Screening and End of Study
timeFrame: Day 42
measure: Vital Signs performed at Screening and End of Study
timeFrame: Day 42
measure: Vital Signs performed at Screening and End of Study
timeFrame: Day 42
measure: Patient diary on treatment application compliance, local tolerance and selfies photo
timeFrame: Day 42
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
Study officials:
affiliation: Centre for Human Drug Research
name: Robert Rissmann, PhD
role: PRINCIPAL_INVESTIGATOR
References: