A randomized controlled proof‐of‐concept trial of digoxin and furosemide in adults with cutaneous warts

The potentially lethal infection caused by the novel Severe Acute Respiratory Disease Coronavirus-2 (SARS-CoV-2) has evolved into a global crisis. Following the initial viral infection is the host inflammatory response that frequently results in excessive secretion of inflammatory cytokines (e.g. , IL-6 and TNFα), developing into a self-targeting, toxic “cytokine storm” causing critical pulmonary tissue damage. The need for a therapeutic that is available immediately is growing daily but the de novo development of a vaccine may take years. Therefore, repurposing of approved drugs offers a promising approach to address this urgent need. Inhaled furosemide, a small molecule capable of inhibiting IL-6 and TNFα, may be an agent capable of treating the Coronavirus Disease 2019 cytokine storm in both resource-rich and developing countries. Furosemide is a “repurpose-able” small molecule therapeutics, that is safe, easily synthesized, handled, and stored, and is available in reasonable quantities worldwide.

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“…Indeed, topical and locally administered furosemide gel has demonstrated efficacy against warts caused by the human papillomavirus. 50 …”

Section: Antiviral Properties Of Furosemidementioning

confidence: 99%

Is Inhaled Furosemide a Potential Therapeutic for COVID-19?

Brennecke

Villar

Wang

et al. 2020

The American Journal of the Medical Sciences

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“…We previously showed that skin swabs can be used for antiviral treatment monitoring for cutaneous warts. 35,36 These studies showed a good correlation of the HPV load between swabs and gold standard biopsies. Performing swabs instead of multiple biopsies has major advantages: a lower patient burden because of its noninvasive nature, the ability to assess the viral load of a single lesion over time and its lack of curative effect, i.e.…”

Section: Discussionmentioning

confidence: 90%

“…This is the first study to show the use of skin swabs as a biomarker in the genital area related to antiviral treatment monitoring. We previously showed that skin swabs can be used for antiviral treatment monitoring for cutaneous warts . These studies showed a good correlation of the HPV load between swabs and gold standard biopsies.…”

Section: Discussionmentioning

confidence: 95%

Results of phase 2 trials exploring the safety and efficacy of omiganan in patients with human papillomavirus‐induced genital lesions

Rijsbergen

Rijneveld

Todd

et al. 2020

Brit J Clinical Pharma

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Funding information Cutanea Life Sciences Aims: To assess safety and tolerability and explore pharmacodynamics and efficacy of omiganan in external anogenital warts (AGW) and vulvar high-grade squamous intraepithelial lesions (HSIL). Methods: Two randomized controlled trials in patients with external AGW and vulvar HSIL were conducted. Patients received topical omiganan 2.5% or placebo gel once daily for 12 weeks with a follow-up of 12 weeks. Safety and tolerability were monitored and pharmacodynamics and clinical efficacy of omiganan were assessed by analysing lesion count, size and viral load. Self-reported pain, itch and quality of life were assessed by an electronic diary and questionnaire. Results: Twenty-four AGW and 12 vulvar HSIL patients were enrolled. All patients had a high treatment adherence (99%). No serious adverse events occurred and all adverse events (n = 27) were mild, transient and self-limiting. The treatment groups were not different in terms of safety and tolerability, lesion count and size, and patient-reported outcomes pain, itch and quality of life. Human papillomavirus load significantly reduced after 12 weeks of treatment with omiganan compared to placebo (-96.6%; 95% confidence interval-99.9 to-7.4%; P = .045) in AGW patients only. Conclusion: Topical omiganan appears to be safe in patients with AGW and vulvar HSIL and reduced human papillomavirus load after 12 weeks of treatment in AGW patients.

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“…The studies were approved by the Dutch Medical Ethics Committee (‘Stichting Beoordeling Ethiek Biomedisch Onderzoek’, Assen, the Netherlands). The clinical efficacy and safety results of these studies have been or will be reported elsewhere …”

Section: Methodsmentioning

confidence: 99%

“…The clinical efficacy and safety results of these studies have been or will be reported elsewhere. [18][19][20][21]…”

Section: Subjects and Designmentioning

confidence: 99%

Mobile e‐diary application facilitates the monitoring of patient‐reported outcomes and a high treatment adherence for clinical trials in dermatology

Rijsbergen

Kolk

Rijneveld

et al. 2019

Acad Dermatol Venereol

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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.

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A randomized controlled proof‐of‐concept trial of digoxin and furosemide in adults with cutaneous warts

Cited by 23 publications

References 40 publications

Is Inhaled Furosemide a Potential Therapeutic for COVID-19?

Is Inhaled Furosemide a Potential Therapeutic for COVID-19?

Results of phase 2 trials exploring the safety and efficacy of omiganan in patients with human papillomavirus‐induced genital lesions

Mobile e‐diary application facilitates the monitoring of patient‐reported outcomes and a high treatment adherence for clinical trials in dermatology

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