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

Primary Purpose

Plantar Wart

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

combined digoxin and furosemide

5 fluorouracil

About this trial

This is an interventional treatment trial for Plantar Wart

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

group A

group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

the change in size of plantar wart

measurement the change in size of plantar wart

the change in number of plantar warts

measurement the change in number of plantar warts

Secondary Outcome Measures

Full Information

NCT ID

NCT05520658

First Posted

August 15, 2022

Last Updated

August 29, 2022

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05520658

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

September 2022 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plantar Wart

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group A

Arm Type

Active Comparator

Arm Description

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

Arm Title

group B

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

combined digoxin and furosemide

Intervention Description

one session every 2 weeks for maximum 6 sessions

Intervention Type

Drug

Intervention Name(s)

5 fluorouracil

Intervention Description

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

Primary Outcome Measure Information:

Title

the change in size of plantar wart

Description

measurement the change in size of plantar wart

Time Frame

3 month

Title

the change in number of plantar warts

Description

measurement the change in number of plantar warts

Time Frame

3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

samah R Ahmed, resident

Phone

01128636414

samah_ragab_post@med.sohag.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Essam A Nada

Facility Information:

Facility Name

Sohag University Hospital

City

Sohag

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Osama R Elshrif, professor

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

31241843

Citation

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.

Results Reference

background

PubMed Identifier

21219294

Citation

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.

Results Reference

background

Learn more about this trial

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

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