Comparison Between the Efficacy and Safety of Topical Podophyllin 25% Versus Cryotherapy in the Treatment of Anogenital Warts
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Efficacy of treatment will be graded as 'excellent' >90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'<30
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
25% podophyllin in treatment of anogenital warts ( Group A )
25% podophyllin resin will be applied topically once weekly for 4 weeks
干预措施: Topical 25% podophyllin (Drug)
cryotherapy for anogenital warts( Group B)
cryotherapy of 10 seconds freeze cycle twice weekly for 04 weeks
干预措施: Cryotherapy (Procedure)
结局指标
主要结局
Efficacy of treatment will be graded as 'excellent' >90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'<30
时间窗: 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.
次要结局
未报告次要终点
研究者
Narjis Batool
Post graduate resident in Dermatology
Sheikh Zayed Medical College