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Comparison Between Efficacy of Topical 25%Podophyllin and Cryotherapy on Genital Warts

NCT06809777 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-05-13

No results posted yet for this study

Summary

Human papilloma virus (HPV), is the major prevalent cause of sexually transmitted disease affecting genitalia, causing Condylomata Accuminata, also known as external genital warts or anogenital warts.¹ Occurring in men and women with a prevalence rate of 0.6-1.2% worldwide. It primarily affects those in the age range of 20-25 years. Human papilloma virus infections subclinically are primarily caused by either type HPV- 6 or HPV- 11.

A vast variety of treatment options are available to treat CA , including immunomodulators ( imiquimod, purified protein derivative and the HPV vaccine), physical ablation ( cryotherapy and electrodessication) and topical cytotoxic drugs ( TCA, phenol, 5- fluorouracil, retinoids, podophyllin and bleomycin)¹ . Although there are multiple effective treatment are present for EGW, no single treatment has been identified as the best ideal way to treat CA.

Cryotherapy causes the destruction of keratinocytes infected with HPV by using below zero temperature and leading to thermal cell necrosis.

Podophyllum peltatum and Podophyllum emodi are the main source of Podophyllin, a refined plant- based resin.¹² It works by attaching itself to the infected cell's microtubule disturbing the linking process which stops the mitotic process during the metaphase stage of cell division causing the death of epithelial cell.

Study will include patients which will be divided into 2 groups A \& B, 48 in each group. Group A will receive topical 25% podophyllin resin via cotton bud under supervision once weekly for 04 weeks. Group B will receive cryotherapy of 10sec freeze cycle twice weekly for 04 weeks. Patient will be followed at interval of 4 weeks and 8 weeks from start of treatment.

Treatment will be considered efficant when decrease in the number of warts is clinically evident at follow up visits. Efficacy of treatment will be graded as 'excellent' \>90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'\<30% clearance.

Conditions

  • Anogenital Human Papilloma Virus Infection

Interventions

DRUG

Topical 25% podophyllin

25% podophyllin applied topically once weekly for 4 weeks

PROCEDURE

Cryotherapy

cryotherapy of 10 sec freeze cycle applied twice weekly for 4 weeks

Sponsors & Collaborators

  • Sheikh Zayed Medical College

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-29
Primary Completion
2025-11-15
Completion
2025-12-10

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06809777 on ClinicalTrials.gov