NL-OMON48691
Completed
Phase 2
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 - Topical ionic contra-viral therapy in actinic keratosis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Actinic keratosis
- Sponsor
- Maruho Co., Ltd.
- Enrollment
- 32
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
Not specified
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