Evaluation of the Efficacy & Safety of Topical Ivermectin Alone or in Combination With Microneedling as Novel Therapeutic Options for Cutaneous Non-genital Warts Versus Topical Salicylic Acid ؛ Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 88
- 主要终点
- evaluation of the efficacy of topical ivermectin in treatment of cutaneous warts.
研究概览
简要总结
To compare between the efficacy and safety of topical ivermectin alone, microneedling with topical ivermectin and topical salicylic acid in treatment of cutaneous warts.
topical ivermectin 1% will be applied on warts whole night clinical assessment will be done every 2 weeks
Microneedling will be performed on the lesion using a microneedling pen type device with a 1-cm tip diameter at a 2-mm depth setting for 2-3 minutes until pinpoint bleebing occurs 1 mL of topical ivermectin 1% will be applied on to the wart tissue.
Sessions: Sessions will be performed every 2 weeks until complete cure or for maximum 6 sessions (total 3 month)
详细描述
Wart is a benign skin growth caused by infection with the human papillomavirus (HPV). These lesions typically appear as rough, raised projections on the skin, often on the hands, feet, or other areas. More than 200 types of HPV have been identified.
Worldwide, warts (due to HPV) are extremely common. Estimates suggest about 7-12% of the global population have cutaneous warts at any given time, and among school-aged children the prevalence can reach 10-20%.
The main types of cutaneous non genital warts are : Common warts, often appears on hands &fingers ,Plantar warts: occur on the soles of the feet, Flat warts occur often on the face, legs.
Warts cause pain (especially plantar types), cosmetic embarrassment, in addition to risk of transmission to others There are several therapeutic modalities for warts: include destructive agents (keratolytics, cryotherapy, curettage and cautery, laser, photodynamic therapy), antimitotic agents (podophyllin, bleomycin, retinoids), immune stimulants (topical sensitizers, cimetidine), and topical virucidal agents (formaldehyde, glutaraldehyde) No single treatment is effective in most of patients, available options often painful ,associated with recurrence and have risks like scarring or infection.
Ivermectin, which is traditionally used as an anti- helminthic agent, has been found to have a range of effects beyond its initial well known anti-parasitic use, that include: immune modulatory, anti-viral and anti- proliferative effect. The immune modulatory effect of Ivermectin depends on it's ability to modulate pro-inflammatory cytokines. It also has antiviral role by inhibition of viral replication, several studies have addressed its antiviral activity against a diverse range of viruses, leading to its exploration for use in treating SARS-CoV-2 during the most recent global pandemic .
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
- Single (Participant)
入排标准
- 年龄范围
- 11 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with cutaneous non genital warts aged 11:80 y.
- •No concurrent systemic or topical treatment of warts
排除标准
- •Genital warts.
- •Pregnancy and lactation.
- •History of any bleeding, clotting disorder or using anticoagulants
- •Chronic systemic diseases such as chronic renal failure, hepaticinsufficiency, and cardiovascular disorders.
- •patients who received any treatment for warts in the last month before the study.
- •Patients with history of neuropathy or peripheral ischemia.
- •Patients with signs of inflammation or infection.
- •Patients with history of a serious systemic or anaphylactic reaction or allergy to ivermectin.
研究组 & 干预措施
topical ivermectin
干预措施: Ivermectin (Drug)
microneedling
patients with cutaneous warts will be treated with microneedling.
干预措施: microneedling (Device)
microneedling with ivermectin
patients with cutaneous warts will be treated with topical ivermectin with microneedling.
干预措施: Ivermectin (Drug)
microneedling with ivermectin
patients with cutaneous warts will be treated with topical ivermectin with microneedling.
干预措施: microneedling (Device)
topical salicylic acid
patients with cutaneous warts will be treated with topical salicylic acid.
干预措施: Salicylic Acid (Drug)
结局指标
主要结局
evaluation of the efficacy of topical ivermectin in treatment of cutaneous warts.
时间窗: baseline
clinical assessment of warts at the baseline \& each visit comparing photographs at different timeline .
次要结局
- evaluation of the efficacy of topical ivermectin combined with microneedling in treatment of cutaneous warts.(baseline)
研究者
Aya Mohamed Sayed Abdelaziz
Doctor
Assiut University