A PROSPECTIVE, RANDOMIZED, OPEN LABEL STUDY ON EFFICACY, SAFETY AND TOLERABILITY OF TOPICAL PERMETHRIN 5 PERCENTAGE VS TOPICAL SPINOSAD 0.9 PERCENTAGE IN MANAGEMENT OF SCABIES
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To assess the clinical efficacy of topical permethrin 5% vs topical spinosad 0.9% in management of scabies
研究概览
简要总结
Scabies is a contagious parasitic infestation of the skin caused by the itch mite Sarcoptes scabiei var.hominis. There are various treatment options available. This is a prospective, randomized open label clinical study to assess the efficacy, safety, and tolerability of topical permethrin 5% vs topical Spinosad 0.9% in the management of scabies. Each group will have 48 patients each. Group A will include patients who will be treated with topical permethrin 5% cream applied locally 8 hours overnight from the neck down, followed by shower the next morning and then repeat in 1 week. Group B will include patients who will be treated with topical Spinosad 0.9% cream applied locally 8 hours overnight from the neck down followed by shower the next morning. Both the groups will be followed up for 4 more weeks thus total duration will be of 6 weeks. Thus the study aims to find the best possible results in management of scabies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are clinically diagnosed case of scabies.
- •Household contacts of the patients.
- •Age include Above 4 years and less than 65 years.
- •Both sexes.
- •Complaint of nocturnal pruritus and papules or excoriation marks over the body.
- •Patient having typical burrows over the web spaces and involvement of flexures of upper limb, axilla, breast, and groins.
排除标准
- •Age less than 4 years, pregnancy, those females planning for pregnancy in next one month and lactation.
- •Atypical variant and scabies with secondary infection.
- •H/O recent live vaccination, other scabicide drugs taken in recent past.
- •Patients with anemia, liver diseases, kidney disease.
- •Patients with malignancies or lymphoproliferative disorders.
- •Patients on potent immunosuppresants, immunocompromised individuals.
- •Family history of melanoma or non melanoma skin cancers.
- •Patients unwilling to participate in the study.
结局指标
主要结局
To assess the clinical efficacy of topical permethrin 5% vs topical spinosad 0.9% in management of scabies
时间窗: Baseline, Week One, Week Two, Week Four, Week six
次要结局
- To assess the safety and tolerability of topical permethrin 5% vs topical spinosad 0.9% in management of scabies(6 weeks)
研究者
DrNoorain Hamid Khan
Shri Bhausaheb Hire Government Medical College