Clinical Trial

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

Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated May 13, 2025 (before its estimated November 15, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-30.
Trial Details
NCT Number NCT06809777
Lead Sponsor Sheikh Zayed Medical College
Conditions Anogenital Human Papilloma Virus Infection
Enrollment 96 participants
Start Date 2025-06-29
Primary Completion 2025-11-15 (estimated)
Study Completion 2025-12-10 (estimated)
Updated on ClinicalTrials.gov 2025-05-13