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

NCT05520658 | Unknown

• 1 other identifier: Soh-Med-22-07-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Warts are common skin infections caused by human papillomavirus (HPV), which can cause a variety of skin presentations according to its type, site and the immune status .Nongenital warts may be presented as common, plane, plantar, filiform, or mucosal warts .Most people are affected by cutaneous warts, either plantar warts or common warts .prevalence of skin warts is between 3% and 13% and plantar warts are about 30% of skin warts in western world .Majority of cases occur in adolescent and young adults

Conditions

Plantar Wart

Outcome Measures

Primary Outcomes (2)

• the change in size of plantar wart

  measurement the change in size of plantar wart

  3 month

• the change in number of plantar warts

  measurement the change in number of plantar warts

  3 month

Study Arms (2)

group A

ACTIVE COMPARATOR

patients will receive intralesional combined digoxin and furosemide , one session every 2 weeks for maximum 6 sessions

Drug: combined digoxin and furosemide

group B

ACTIVE COMPARATOR

patients will receive intralesional 5 fluorouracil mixed with 1ml of 2% lignocaine and epinephrine one session every 2 weeks for maximum 6 sessions .

Drug: 5 fluorouracil

Interventions

combined digoxin and furosemide DRUG

one session every 2 weeks for maximum 6 sessions

group A

5 fluorouracil DRUG

5 fluorouracil mixed with1ml of 2% lignocaine and epinephrine one session every 2 weeks for maximum 6 sessions .

group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age:\>18 years .
• Sex: both males and females will be included.
• Confirmed diagnosis by clinical and dermoscopic examination of plantar warts will be made

You may not qualify if:

• Patients with history or evidenced hypersensitivity to any component used in this study.
• Pregnancy \& lactating.
• Patients who receive immune suppressive therapy.
• Patients who receive any wart treatment during the last 2 months before enrollment in the study.
• Patients with systemic illness especially cardiac patients.
• Patients who refused participation in the study

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (2)

• Abeck D, Tetsch L, Luftl M, Biedermann T. Extragenital cutaneous warts - clinical presentation, diagnosis and treatment. J Dtsch Dermatol Ges. 2019 Jun;17(6):613-634. doi: 10.1111/ddg.13878.

  PMID: 31241843 BACKGROUND

• Kwok CS, Holland R, Gibbs S. Efficacy of topical treatments for cutaneous warts: a meta-analysis and pooled analysis of randomized controlled trials. Br J Dermatol. 2011 Aug;165(2):233-46. doi: 10.1111/j.1365-2133.2011.10218.x. Epub 2011 May 26.

  PMID: 21219294 BACKGROUND

MeSH Terms

Interventions

Furosemide; Fluorouracil

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

samah R Ahmed, resident

CONTACT

01128636414; samah_ragab_post@med.sohag.edu.eg

Essam A Nada

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at dermatology department at sohag teaching hospital

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 30, 2022
• Study Start: July 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

EG (1)