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Background: Assessment of treatment effects in clinical trials requires valid information on treatment adherence, adverse events and symptoms. Paper‐based diaries are often inconvenient and have limited reliability, particularly for outpatient trials. Objectives: To investigate the utility of an electronic diary (e‐diary) application for patients with skin diseases in outpatient clinical trials. Methods: An e‐diary application was developed and technically validated. Treatment adherence was defined as topical administration by the patient, and patient‐reported outcomes, i.e. pain and itch, were evaluated by the e‐diary in six clinical trials on newly tested topical drugs. Additionally, the proportion of patients capturing the applied topical drug by camera and filling in the pain and itch scores was defined as e‐diary adherence, and patients' perception of usefulness and acceptability of the e‐diary were evaluated. Results: Treatment adherence rates of the included 256 patients were high (median 98%, range 97–99%). E‐diary adherence was also high with a median of 93% (range 87–97%) for capturing the applied drug by camera, and 89% (range 87–96%) and 94% (range 87–96%) for entering respectively the itch and pain score. Daily symptom scores provided good insights into the disease burden, and patients rated the e‐diary as good to excellent with respect to user acceptability. Conclusions: The results suggest that the e‐diary is an excellent way to ensure proper treatment administration, indicated by both the high user acceptability scores and high treatment adherence. Moreover, the e‐diary may also be valuable for frequent and reliable monitoring of patient‐reported outcomes in daily clinical practice. [ABSTRACT FROM AUTHOR]

Background DNA viruses such as HPV rely on K+ influx for replication. Both digoxin and furosemide inhibit the K+ influx by interacting with cell membrane ion co-transporters (Na+/K+- ATPase and Na+-K+-2Cl− co-transporter-1, respectively). We therefore hypothesized that these two compounds in a topical formulation may be valuable in the treatment of HPV-induced warts. This new approach is called Ionic Contra-Viral Therapy ( ICVT). Objective To evaluate systemic exposure, safety and tolerability of ICVT with a combination of furosemide and digoxin after repeated topical application in subjects with common warts. Furthermore, we aimed to evaluate pharmacodynamics effects of ICVT. Methods Twelve healthy subjects with at least four common warts on their hands were included in the study and treated with a fixed dose of 980 mg topical gel containing 0.125% (w/w) digoxin and 0.125% (w/w) furosemide for 7 consecutive days on their lower back to assess safety and systemic exposure. Two warts were treated with 10 mg each and two served as negative controls to obtain preliminary evidence of treatment effect. Results ICVT was well tolerated topically, and there was no evidence of systemic exposure of digoxin or furosemide. There were no clinical relevant safety findings and no serious adverse events ( SAEs). A rapid and statistically significant reduction in diameter, height and volume of the warts was already observed at day 14. Conclusion ICVT was found to be safe for administration to humans and 7 days of active treatment showed a statistical significant wart reduction compared to untreated control lesions, clearly indicating pharmacological activity. [ABSTRACT FROM AUTHOR]

Current therapies for AGW have notable side-effects and high recurrence rates.[1] As DNA viruses such as HPV rely on cellular K+ influx and ionic contra-viral therapy (ICVT) comprised of digoxin and furosemide inhibits the K+ influx, ICVT might be a potential new treatment for AGW. In the current study, 79% of patients had undergone a minimum of one previous treatment for AGW and 50% had undergone 2-6 different previous treatments indicating treatment resistance. In conclusion, ICVT demonstrates to be safe to administer in patients with AGW but shows no pharmacodynamic activity or clinical efficacy after 6 weeks of treatment. [Extracted from the article]