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NCT Number: NCT06809777

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

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.

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Key information

Conditions

Anogenital Human Papilloma Virus Infection Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sheikh zayed Medical College and Hospital

Rahim Yar Khan, Punjab Province, 64200, Pakistan

About this study

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. 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.Topical medicines, surgeries and other treatment are among the many possible therapeutic options available. However recurrence and treatment failure are observed with almost all the available treatment after the warts have been visibly cleared.

EGW management poses a major obstacle therapeutically . The patient's immunological condition determine the outcome of the warts , if they are left untreated , they could go away spontaneously, get bigger in size and numerous , or remain the same. The treatment goal is to remove visible warts in order to potentially reduce their infectious , if not the carcinogenic properties.

In this study we will compare the efficacy of topical 25% podophyllin resin versus cryotherapy for the treatment of warts .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Topical 25% podophyllin

Drug

25% podophyllin applied topically once weekly for 4 weeks

cryotherapy

Procedure

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

Primary outcomes

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

Time frame: 6 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Narjis Batool, Post graduate resident

CONTACT

[email protected]

+923042937478

Sponsors and collaborators

Lead sponsor

Sheikh Zayed Medical College

Other Gov

Registry information

Official study title

Comparison Between the Efficacy and Safety of Topical Podophyllin 25% Versus Cryotherapy in the Treatment of Anogenital Warts

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Feb 5, 2025
Registry last updated: May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed