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

Official title

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

Overview

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.

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

Primary outcome measures

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Sheikh zayed Medical College and Hospital — Rahim Yar Khan

Identifiers

NCT: NCT06809777 · SheikhZyMC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗