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

NCT ID: NCT05520658

Last Updated: 2022-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2022-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group A

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

Group Type: ACTIVE_COMPARATOR

combined digoxin and furosemide

Intervention Type: DRUG

one session every 2 weeks for maximum 6 sessions

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 .

Group Type: ACTIVE_COMPARATOR

5 fluorouracil

Intervention Type: DRUG

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

Interventions

combined digoxin and furosemide

one session every 2 weeks for maximum 6 sessions

Intervention Type: DRUG

5 fluorouracil

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Samah Ragab Ahmed

resident doctor at dermatology department at sohag teaching hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University Hospital

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

samah R Ahmed, resident

Role: CONTACT

samah_ragab_post@med.sohag.edu.eg

01128636414

Essam A Nada

Role: CONTACT

Facility Contacts

Osama R Elshrif, professor

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 31241843 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21219294 (View on PubMed)

Other Identifiers

Soh-Med-22-07-01

Identifier Type: -

Identifier Source: org_study_id