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

NCT ID: NCT06809777

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-29
• Study Completion Date: 2025-12-10

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.

Detailed Description

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 .

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

Study Design

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

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

Topical 25% podophyllin

Intervention Type: DRUG

25% podophyllin applied topically once weekly for 4 weeks

cryotherapy for anogenital warts( Group B)

cryotherapy of 10 seconds freeze cycle twice weekly for 04 weeks

Group Type: ACTIVE_COMPARATOR

Cryotherapy

Intervention Type: PROCEDURE

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

Interventions

Topical 25% podophyllin

25% podophyllin applied topically once weekly for 4 weeks

Intervention Type: DRUG

Cryotherapy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheikh Zayed Medical College

OTHER_GOV

Sponsor Role: lead

Responsible Party

Narjis Batool

Post graduate resident in Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sheikh zayed Medical College and Hospital

Rahim Yar Khan, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Narjis Batool, Post graduate resident

Role: CONTACT

drnarjis99@gmail.com

+923042937478

Other Identifiers

SheikhZyMC

Identifier Type: -

Identifier Source: org_study_id