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

NCT06809777 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SheikhZyMC
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anogenital warts; Topical 25% podophyllin; cryotherapy

Outcome Measures

Primary Outcomes (1)

• Efficacy of treatment will be graded as 'excellent' >90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'<30

  Treatment will be considered efficant when decrease in the number of warts is clinically evident at follow up visits at 4 weeks and 8 weeks after the start of treatment. Efficacy of treatment will be graded as 'excellent' \>90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'\<30% clearance.

  6 months

Study Arms (2)

25% podophyllin in treatment of anogenital warts ( Group A )

ACTIVE COMPARATOR

25% podophyllin resin will be applied topically once weekly for 4 weeks

Drug: Topical 25% podophyllin

cryotherapy for anogenital warts( Group B)

ACTIVE COMPARATOR

cryotherapy of 10 seconds freeze cycle twice weekly for 04 weeks

Procedure: Cryotherapy

Interventions

Topical 25% podophyllin DRUG

25% podophyllin applied topically once weekly for 4 weeks

25% podophyllin in treatment of anogenital warts ( Group A )

Cryotherapy PROCEDURE

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

cryotherapy for anogenital warts( Group B)

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: 16-60years
• Gender: Any gender
• All new clinically diagnosed cases of plane warts
• Type of warts: plane warts
• Area: Ano-genital warts
• Size: Less than 10cm2(cummulative)
• No. of warts: Upto 20
• Duration of disease: Any

You may not qualify if:

• Pregnancy and lactating females
• Bleeding disorders
• Immunocompromised patients.
• Diabetic patients / Peripheral vascular disease.
• Bleeding warts, moles, birthmarks.
• Any other inflammatory dermatosis on that area
• History of any previous treatment in last 2 months.
• Liver/Renal disease
• Hypersensitivity to Podophyllin.

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

Study Sites (1)

Sheikh zayed Medical College and Hospital

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

Podophyllin; Cryotherapy

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Therapeutics

Central Study Contacts

Narjis Batool, Post graduate resident

CONTACT

+923042937478; drnarjis99@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduate resident in Dermatology

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: June 29, 2025
• Primary Completion: November 15, 2025
• Study Completion: December 10, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)