A Randomized, Double-Blind, Multicentric, Parallel group, comparative clinical study of Permethrin 5% cream of Morningside Healthcare Limited, UK (Test) vs Permethrin 5% cream of Medgenix Benelux NV (Belgium) (Reference) for the treatment of scabies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- •Proportion of responder during the 28 days will be compared between treatments. The responder will be defined as patients with no scabies remaining and at least 50% improvement in the VAS score for pruritus.
研究概览
简要总结
A Randomized, Double-Blind, Multicentric, Parallel group, comparative clinical study of Permethrin 5% cream of Morningside Healthcare Limited, UK (Test) vs Permethrin 5% cream of Medgenix Benelux NV (Belgium) (Reference) for the treatment of scabies. Subject with diagnosis of scabies who meet all the eligibility criteria, based on medical history and clinical examination will be screened in this study. The study will include 90 subjects of scabies.
Screened subjects will be evaluated and the eligible subjects will be enrolled in the study. Subjects will be called for 7, 14 and 28 days. For all subjects, dermoscopic and microscopic evaluation for the presence of mite will be done on every visit. Primary endpoint assessment will be compared between treatments and there should be atleast 50 % improvement in VAS score for pruritus. Secondary assessment endpoint will be Dermoscopy & confirmation of absence of mites, eggs/ova and/or mite feces by Microscopy
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject is in good general health with normal appearing skin in non infected areas.
- •3.Clinical findings typical of scabies (burrows, erythematous papules, etc.) and microscopic confirmation of scabies mite, ova, or mite feces at classical sites.
- •4.Subject is able to provide written informed consent prior to study.
- •5.Willingness to comply with the study schedule and procedures.
排除标准
- •1.Subjects with any condition which in opinion of the investigator makes the subject unsuitable for inclusion.
- •2.Skin conditions that could make it difficult to evaluate the extent of an infestation or would present a problem in the evaluation of response to therapy (e.g. atopic dermatitis, eczema, contact dermatitis, lichen planus, papular urticaria, seborrheic dermatitis).
- •3.Subjects used following within 4 weeks of baseline visit 1 immunomodulators 2 systemic medications that suppress the immune system 3 topical or oral parasiticides.
- •4.Subject used following within 2 weeks of baseline visit (1) topical steroids (2) topical or systemic antibiotics.
- •5.Subject has crusted scabies.
- •6.Subject with known history of irritation or sensitivity to parasiticides.
- •7.Known allergy or hypersensitivity to permethrin, any synthetic pyrethroid or pyrethrin, plants in the Asteraceae/Compositae family (e.g. chrysanthemums, ragweed, marigolds, and daisies).
- •8.Subjects whose household members and close contacts refuse treatment.
- •9.Subjects whose sexual contacts do not agree to restrict prolonged skin to skin contact with non-household members during the study period.
- •10.Subjects with a household member less than 2 months of age.
- •11.Subject with signs of systemic infection or is receiving systemic therapy for an infectious disease.
- •12.Subjects with secondary bacterial infection based on subjective evidence.
- •13.Subjects with skin wounds, open injuries or other conditions of broken skin at the site of proposed application.
- •14.Subjects with history of severe cardiac, central nervous system, immunodeficiency, diabetes mellitus, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
- •15.Subject is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.
- •16.Participation in any other clinical trial during last 30 days.
结局指标
主要结局
•Proportion of responder during the 28 days will be compared between treatments. The responder will be defined as patients with no scabies remaining and at least 50% improvement in the VAS score for pruritus.
时间窗: 28 days
次要结局
- Dermoscopy & confirmation of absence of mites, eggs/ova and/or mite feces by Microscopy.(Reported reduction or absence of pruritus (itching).)