Clinical trial · Interventional
Topical Ionic Contra-Viral Therapy in Actinic Keratosis
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
NCT03684772CI-TRIAL-00038398unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digoxin Topical Gel | Drug | — | UNRESOLVED |
| Furosemide Topical Gel | Drug | — | UNRESOLVED |
| ICVT Topical Gel | Drug | — | UNRESOLVED |
| Vehicle Topical Gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- ICVT
- description
- Digoxin and Furosemide (0.125%)
- interventionNames
- Drug: ICVT Topical Gel
- type
- EXPERIMENTAL
- label
- Furosemide
- description
- Furosemide (0.125%)
- interventionNames
- Drug: Furosemide Topical Gel
- type
- EXPERIMENTAL
- label
- Digoxin
- description
- Digoxin (0.125%)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.