Topical Ionic Contra-Viral Therapy in Actinic Keratosis

NCT ID: NCT03684772

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-22
• Study Completion Date: 2019-09-30

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.

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ICVT

Digoxin and Furosemide (0.125%)

Group Type: EXPERIMENTAL

ICVT Topical Gel

Intervention Type: DRUG

Digoxin and Furosemide (0.125%)

Furosemide

Furosemide (0.125%)

Group Type: EXPERIMENTAL

Furosemide Topical Gel

Intervention Type: DRUG

Furosemide (0.125%)

Digoxin

Digoxin (0.125%)

Group Type: EXPERIMENTAL

Digoxin Topical Gel

Intervention Type: DRUG

Digoxin (0.125%)

Placebo

Vehicle Gel

Group Type: PLACEBO_COMPARATOR

Vehicle Topical Gel

Intervention Type: DRUG

Vehicle Gel

Interventions

ICVT Topical Gel

Digoxin and Furosemide (0.125%)

Intervention Type: DRUG

Furosemide Topical Gel

Furosemide (0.125%)

Intervention Type: DRUG

Digoxin Topical Gel

Digoxin (0.125%)

Intervention Type: DRUG

Vehicle Topical Gel

Vehicle Gel

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maruho Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Rissmann, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Human Drug Research

Locations

Centre for Human Drug Research

Leiden, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Robert Rissmann, PhD

Role: CONTACT

clintrials@chdr.nl

+ 31 71 5246 400

Facility Contacts

Robert Rissmann, PhD

Role: primary

clintrials@chdr.nl

+ 31 (0)71 5246400

Other Identifiers

CLS003-CO-PR-004

Identifier Type: -

Identifier Source: org_study_id