Efficacy and Safety of Platelet-rich Plasma, Metformin and Cryotherapy in Treatment of Non-genital Warts
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 108
- 主要终点
- Complete resolution of the wart(s) by disappearance of the wart and return of the normal skin markings
研究概览
简要总结
- Evaluation of the efficacy and safety of intralesional injection of autologous platelet-rich plasma in treatment of various types of cutaneous non genital warts
- Evaluation of the efficacy and safety of intralesional injection of metformin in treatment of various types of cutaneous non genital warts
- Comparing the efficacy and safety of intralesional injection of autologous platelet-rich plasma and intralesional injection of metformin with that of cryocautery in treatment of various types of cutaneous non genital warts.
详细描述
Cutaneous warts caused by human papillomavirus (HPV) are benign proliferative lesions that occur at any age in human life.
More than 100 different types of HPVs have been fully characterized . Warts may exist in different forms according to the epithelial surface affected and HPV type responsible for the infection. Common warts (Verruca vulgaris), plantar warts (Verruca plantaris), flat or plane warts (Verruca plana) and genital warts (Condyloma acuminata) are some of the clinical manifestations of HPV infection .
Although lesions can resolve spontaneously within 2 years without treatment, treatment is sought by many who are unwilling to wait for spontaneous clearance, by those who do not experience such resolution and for reasons of preventing infections of other individuals and reducing the risk of malignancy . Additionally, pain, discomfort, recurrent bleeding, functional limitation, and esthetic disfigurements due to cutaneous warts are common indications for seeking treatment.
Several therapeutic modalities have been used to treat HPV infections. The choice of treatment should take into account factors such as age, location, number and size of the lesions, clinical subtype and the patient's immunological status.
Available treatments are aimed at either breakdown or removal of visible warts or induction of cytotoxicity against infected cells .
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, Care Provider)
入排标准
- 年龄范围
- 8 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with cutaneous (extragenital) viral warts (single , new or recurrent, common, plane and/or planter warts.
- •Age ranged from 8 to 60 years old.
- •No concurrent systemic or topical treatment of warts.
排除标准
- •Patients with fever or signs of any inflammation or infection
- •Pregnancy and lactation.
- •Immunosuppression or being under any kind of treatment causing absolute or relative immunosuppression.
- •History of any bleeding, clotting disorder or using anticoagulants
- •Chronic systemic diseases such as diabetes, chronic renal failure, hepatic insufficiency, and cardiovascular disorders.
- •atients using concurrent treatments for warts or one month before .
- •Any generalized dermatitis, allergic skin disorders
研究组 & 干预措施
Intralesional injection of Metformin
Group 1: will include 36 patients with multiple common, plantar and/or plane warts. They will be treated by intralesional injection of metformin using insulin syringe every 2-weeks until complete clearance or for a maximum of 6 sessions.
干预措施: Metformin (Drug)
Intralesional injection of platelet- rich plasma
Group 2: will include 36 patients with multiple common, plantar and/or plane warts. They will be treated by intralesional injection of platelet- rich plasma into the warts by an insulin syringe every 2 weeks until complete clearance or for a maximum of 6 sessions
干预措施: platelet-rich plasma (Drug)
Cryotherapy
Group 3: will include 36 patients with multiple common, plantar and/or plane warts. They will receive cryotherapy sessions every two weeks until complete clearance or for a maximum of 6 sessions.
干预措施: cryotherapy (Other)
结局指标
主要结局
Complete resolution of the wart(s) by disappearance of the wart and return of the normal skin markings
时间窗: 3 months
Complete resolution of the wart(s) by disappearance of the wart and return of the normal skin markings
次要结局
- •Change in size in millemeter(3 months)
- •Decrease in numbers of the warts(3 months)
- •Recurrence rates at 3 months for wart(s) with complete resolution.(3 months)
研究者
Aya Gamal Abd El-Wahab Mahmoud
principal investigator
Assiut University