Infections

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Hepatitis A

Hepatitis

Hepatitis B

Warts

Liver Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

Virus Diseases

Communicable Diseases

Enterovirus Infections

Picornaviridae Infections

RNA Virus Infections

Blood-Borne Infections

Hepadnaviridae Infections

DNA Virus Infections

Papillomavirus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

All Drugs and Chemicals

Vaccines

Immunomodulating Agents

Immunologic Factors

0.2 ml of hepatitis B vaccine injected in the largest wart and repeated every 2 weeks till clearance of warts or for a maximum of 5 sessions

0.5 ml injected in the deltoid muscle for those who were younger than 19 years at the time of study and 1 ml for those who were 20 years and older at the time of study.

Three injections were done at 0, 1, and 4 months.

0.2 ml of saline injected in the largest wart and repeated every 2 weeks till clearance of warts or for a maximum of 5 sessions

Randomized placebo-controlled comparative effectiveness clinical trial

hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)

Intralesional saline

Assessment of the effectiveness of intralesional and intramuscular hepatitis B vaccine in treatment of multiple common warts.

Recently, intralesional immunotherapy by different antigens, including Candida antigen and purified protein derivative PPD has been proved effective in the treatment of different types of warts. Hepatitis B vaccine is one of the DNA vaccines that are regarded as being potentially safer, relatively cheap and easy to produce with no special storage requirements because they are extremely stable and allow for potential simultaneous immunization against multiple antigens or pathogens via co-expression of multiple epitopes on single plasmid. Hepatitis B vaccine could be a promising immunotherapeutic vaccine in the field of intralesional immunotherapy of warts. Moreover, the efficacy of intramuscular injection of hepatitis B vaccine would be assessed and compared to its intralesional injection.

Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts

Intralesional or Intramuscular Hepatitis B Vaccine Versus Intralesional Saline in the Treatment of Multiple Common Warts

Percentage of patients showing complete response to intralesional hepatitis B vaccine and intramuscular hepatitis B vaccine.

Complete response: complete disappearance of warts including distant warts and complete return of normal skin markings (100%).

Partial response: if the warts have regressed in size by 50-99%. No response: less than 50% decrease in wart size.

Percentage of patients showing complete response of their distant warts to intralesional hepatitis B vaccine and intramuscular hepatitis B vaccine.

Complete response: complete disappearance of distant warts and complete return of normal skin markings (100%).

Partial response: if the distant warts have regressed in size by 50-99%. No response: less than 50% decrease in distant wart size.

Zagazig University

Clinical professor

Musculoskeletal Diseases

Foot Diseases

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Antineoplastic Agents

Hypoglycemic Agents

Analgesics

Pharmaceutical Solutions

Cardiotonic Agents

Natriuretic Agents

Lidocaine

Fluorouracil

Insulin

Insulin, Globin Zinc

Digoxin

Furosemide

Antimetabolites

Immunosuppressive Agents

Diuretics

Sodium Potassium Chloride Symporter Inhibitors

Enzyme Inhibitors

Protective Agents

15 patients will receive intralesional 0.1 mL of combined digoxin and furosemide, with maximum 5 warts per session.

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.

15 patients will receive intralesional saline.

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.

intralesional combined digoxin and furosemide

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.

intralesional injection of 5- Fluorouracil

15 patients will receive intralesional saline. Selected patients will receive one session every 2 weeks till complete clearance or up to 5 sessions.

intralesional saline

Nourhan AN Anis, MD

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.

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).

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

The studied warts will be clinically evaluated regarding change in size

The patients will be categorized in to 4 scores according to their response to treatment as:

Score 0: patients showed neither clinical response nor dermoscopic clearance of warts 2 weeks after the last treatment session.

Score 1: patients showed clinical improvement with decreased size of wart and thickness of callus without dermoscopic clearance of warts 2 weeks after the last treatment session.

Score 2: patients showed disappearance of warts clinically (clinical clearance) but dermoscopic examination revealed remnants of warts 2 weeks after the last treatment session.

Score 3: patients showed clinical and dermoscopic clearance of warts 2 weeks after the last treatment session (Barkat et al., 2018).

Immediate and late adverse effects will be evaluated

Patients' satisfaction will be evaluated through a questionnaire. Patients' satisfaction will be graded into (very satisfied, satisfied, and unsatisfied).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts	NCT05326152	Intralesional V...	hepatitis B vac... Intralesional s...	10 Years - 60 Years	Zagazig University
Intralesional Injection of Combined Digoxin and Furosemide Versus 5-Flurouracil in Plantar Warts	NCT05599971	Plantar Wart	intralesional c... intralesional i... intralesional s...	18 Years - 65 Years	Zagazig University

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