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
- Conditions
- 10014982Actinic keratosis
- Registration Number
- NL-OMON48691
- Lead Sponsor
- Maruho Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
For enrollment of subjects the following criteria must be met:
1. Male and female subjects *18 years with a condition of general good health
(with the exception of AK). The health status is verified by absence of
evidence of any clinical significant active or uncontrolled chronic disease
other than AK following a detailed medical history, a complete physical
examination including vital signs, 12-lead ECG, hematology, blood chemistry,
virology and urinalysis;
2. Confirmed clinical AK diagnosis by dermatologist (biopsy proven after end of
study, in untreated part of the AK field)
3. At least 2 facial fields of at least 25 cm2 (but preferably >35 cm2) present
at screening and baseline visit where at least 2 AK lesions are visible in each
field (preferably the forehead, temple or cheek)
4. Able to participate and willing to give written informed consent and to
comply with the study restrictions.
5. Ability to communicate well with the investigator in Dutch.
6. Willing to refrain from using other topical products in the treatment area,
or prohibited medications for the duration of the study.
7. Willing to limit sun exposure of the involved skin to the extent
vocationally possible.
8. 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.
Eligible subjects must meet none of the following exclusion criteria:
1. 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)
2. Have any current pathologically relevant skin conditions in the field area
other than AK (e.g. squamous cell carcinoma or basal cell carcinoma).
3. Have a known hypersensitivity to any of the investigational product
ingredients, including digoxin and furosemide.
4. Current use of systemic digoxin or furosemide.
5. Participation in an investigational drug or device study within 3 months
prior to screening or more than 4 times a year
6. 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.
7. If a woman of childbearing potential, pregnant, or breast-feeding, or
planning to become pregnant during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method