Topical Ionic Contra-Viral Therapy in Actinic Keratosis

Maruho

Status and phase: Unknown; Phase 2

Conditions: Actinic Keratosis

Treatments: Drug: Furosemide Topical Gel; Drug: Vehicle Topical Gel; Drug: Digoxin Topical Gel; Drug: ICVT Topical Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03684772

CLS003-CO-PR-004

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 4 patient groups, including a placebo group

ICVT

Experimental group

Description:

Digoxin and Furosemide (0.125%)

Treatment:

Drug: ICVT Topical Gel

Furosemide

Experimental group

Description:

Furosemide (0.125%)

Treatment:

Drug: Furosemide Topical Gel

Digoxin

Experimental group

Description:

Digoxin (0.125%)

Treatment:

Drug: Digoxin Topical Gel

Placebo

Placebo Comparator group

Description:

Vehicle Gel

Treatment:

Drug: Vehicle Topical Gel