Efficacy of Tazarotene Versus Topical 5-Fluorouracil, and Imiquimod in The Treatment of Verruca Plana
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The proportion of patients with complete clearance of flat warts (Physician Wart Assessment scale PWA = 0) at the end in the four arms of the clinical trial.
研究概览
简要总结
Verruca plana is a common skin infection with worldwide distribution. Approximately 10% of general population is infected with flat warts and it represents up to 18 % of the patients seeking treatment for warts. Verruca plana is not merely an infectious disease but also affects the quality of patients' life. Verruca plana causes major cosmetic and social concerns. Lesions' persistence and recurrence cause frustrations and psychological distress which motivate patients to seek different treatment strategies. Verruca plana commonly affects the school aged children which augments its effect on the psychological and social development of children with stigmatization and bullying are great risks. The available treatment strategies neither ensured complete clearance of the disease nor were free of side effects. Frequently used physical removal methods are operator dependent and commonly lead to irritation, local inflammation, scars, dyspigmentation, and disfigurement. In this study we evaluate the efficacy and the safety of tazarotene gel 0.1% in the treatment of verruca plana compared to imiquimod or 5-fluorouracil
详细描述
Patients will be assigned randomly into one of 4 groups as 1:1:1:1 using randomization.com with the seed number 7607
- Group (A): Patients will be treated with topical tazarotene gel 0.1%with a cotton tipped applicator on every lesion once daily at night.
- Group (B): Patients will be treated with topical 5- fluorouracil 5% cream applied once daily at night.
- Group (C): Patients will be treated with imiquimod cream 5% applied once daily at night.
- Group (D): Patients will be treated with petroleum jelly once daily at night.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants must be willing to sign informed consent; for patients younger than 18 years old, parents or guardians will sign an informed consent
- •Age > 4 years.
- •Both sexes.
- •Patients with clinically and dermoscopically diagnosed plane warts.
- •Subject is willing and able to follow all study instructions and to attend all study visits
排除标准
- •• History of hypersensitivity to any of the drugs used.
- •Pregnancy and lactation.
- •Patients with epidermodysplasia verruciformis syndrome.
- •Patients with eczematous skin disorders.
- •Presence of any active infections e.g. herpes, tuberculosis.
- •History of topical anti wart treatment within 4 weeks of recruitment to the study, and a 12-week period for systemic anti-wart treatment, or immunotherapy, or HPV vaccine in the last 24 weeks.
研究组 & 干预措施
Tazarotene
20 patients of verruca plana receiving daily topical Tazarotene 0.1% gel at night
干预措施: Tazarotene 0.1% Gel,Top (Drug)
Imiquimod
20 patients with verruca plana will be treated with imiquimod cream 5% applied once daily at night
干预措施: Imiquimod (Drug)
5- fluorouracil
20 patients with verruca plana will be treated with topical 5- fluorouracil 5% cream applied once daily at night
干预措施: Fluorouracil Cream (Drug)
Petrolatum
20 patients with verruca plana will be treated with petroleum jelly once daily at night.
干预措施: Petrolatum (Drug)
结局指标
主要结局
The proportion of patients with complete clearance of flat warts (Physician Wart Assessment scale PWA = 0) at the end in the four arms of the clinical trial.
时间窗: Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first
Complete clearance is defined by complete disappearance of the warts and return to normal skin markings
The incidence of adverse events measured by the percentage of participants developing them in the four arms of the study
时间窗: Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first
次要结局
- The patients' adherence to treatment measured by the percentage of missed doses in each arm of the trials(at the end of 12 weeks study period)
- The proportion of patients achieving poor response (<50% of warts disappeared) or partial response (> 50%-99% of warts disappeared)(Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first)
- The mean percent of warts achieving PWA 0 (complete clearance) per-participant across the different arms of the clinical trial(Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first)
- The patients' adherence to treatment measured by the percentage of patients withdrawn from each arm of the trial(at the end of 12 weeks study period)
- The median time for participants to achieve clearance of all warts in the different arms of the clinical trial.(Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first)
- The quality of life index measured by the difference in the wart specific Dermatology Life Quality Index at the end of the trial compared to the baseline(at the end of 6 months period follow up)
研究者
Hagar Nofal
Lecturer, Principal Investigator
Zagazig University