NCT05599971

Intralesional Injection of Combined Digoxin and Furosemide Versus 5-Flurouracil in Plantar Warts

The Efficacy of Intralesional Injection of Combined Digoxin and Furosemide Versus 5-Flurouracil in the Treatment of Plantar Warts

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of the current work is to evaluate the efficacy and safety of intralesional combined Digoxin and furosemide versus intralesional 5-flurouracil in the treatment of plantar warts.

Detailed description

Warts are benign proliferations of skin and mucosa caused by the human papilloma virus (HPV). Currently, over 170 HPV types have been identified. Certain HPV types tend to infect skin at specific anatomical sites, such as palmoplantar warts, which are typically caused by serotypes 1, 2, and 4, however warts caused by any HPV type can occur at any site (Tulay \& Serakinci, 2016). Plantar warts most commonly present with pain that occur with activities that put pressure on the soles of the feet. They commonly affect plantar areas of increased pressure, such as the heels or metatarsal heads. On gross inspection, plantar warts may appear as a singular rough, flesh-colored to yellow or grey-brown, hyperkeratotic papule, or a thickened "cobblestoned" plaque, termed a mosaic wart, which consists of multiple plantar warts that have coalesced (Witchey et al., 2018). There are several modalities for the treatment of warts including, cryotherapy, electrocoagulation, topical salicylic acid, topical 5-fluorouracil, intralesional immunotherapy, and laser surgery. All these treatment options can be painful, time-consuming, and/or expensive, and none is considered the gold standard (Latif et al., 2021). K+ influx is essential for the replication of DNA viruses, such as HPV. Both digoxin, which is a cardiac glycoside, and furosemide, which is a loop diuretic, inhibit the K+ influx by interacting with cell membrane ion co-transporters (Na+/K+-ATPase and Na+-K+-2Cl-co-transporter-1). Therefore, it is hypothesized that these two compounds may be valuable in the treatment of HPV-induced warts. This new approach is called ionic contra-viral therapy (Rijsbergen et al., 2019). Intralesional injection of combined digoxin and furosemide was found to be safe and effective as a treatment option for multiple plantar warts (Fathy et al., 2021). 5-Fluorouracil (5-FU) is an antimetabolite that can be used alone or with other chemotherapeutic agents to treat solid tumors. It is one of the pyrimidine analogues. Due to its structure, 5-FU disrupts nucleoside metabolism and can be integrated into the single and double helix of RNA and DNA, respectively, causing cell cytotoxicity and death (Zoheir et al., 2022). Intralesional 5-fluorouarcil has been found to be a highly effective, safe and cheap alternative in the treatment of warts, with a significantly good response in genital warts also (Kamal et al., 2108).

Conditions

• Plantar Wart

Interventions

Type	Name	Description
DRUG	intralesional combined digoxin and furosemide	15 patients will receive intralesional combined digoxin and furosemide, with maximum 5 warts per session. 0.2 mL of lignocaine (20 mg/mL) will be used as a local analgesic and after few minutes, 0.1 mL of combined digoxin and furosemide solution will be slowly injected into the base of each wart. Selected patients will receive one session every 2 weeks till complete clearance or up to 5 sessions.
DRUG	intralesional injection of 5- Fluorouracil	15 patients will receive intralesional injection of 5- Fluorouracil (50mg/ml) in full concentration into the wart using a 27- gauge insulin syringe till the entire lesion begins to puff up. The maximum dose injected per session will be 2ml of 5-FU. Selected patients will receive one session every 2 weeks till complete clearance or up to 5 sessions.
OTHER	intralesional saline	15 patients will receive intralesional saline. Selected patients will receive one session every 2 weeks till complete clearance or up to 5 sessions.

Timeline

• Start date: 2023-02-22
• Primary completion: 2023-11-01
• Completion: 2024-02-01
• First posted: 2022-10-31
• Last updated: 2023-02-21