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

August 29, 2022 updated by: Samah Ragab Ahmed, Sohag University
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Essam A Nada

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: group A
patients will receive intralesional combined digoxin and furosemide , one session every 2 weeks for maximum 6 sessions
Drug: combined digoxin and furosemide
one session every 2 weeks for maximum 6 sessions
ACTIVE_COMPARATOR: group B
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
5 fluorouracil mixed with1ml of 2% lignocaine and epinephrine one session every 2 weeks for maximum 6 sessions .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change in size of plantar wart
Time Frame: 3 month
measurement the change in size of plantar wart
3 month
the change in number of plantar warts
Time Frame: 3 month
measurement the change in number of plantar warts
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2022

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

August 29, 2022

First Posted (ACTUAL)

August 30, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-07-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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