CTRI/2018/01/011266已完成未知
A Randomized, Open label, Multicentric, Parallel-group, Three Arm Clinical Study to Compare the Efficacy and Safety of Test formulations of Permethrin 5% of Glasshouse Pharmaceuticals Limited Canada versus Elimite® (Permethrin) 5% Cream of Prestium Pharma, Inc. in adult Subjects with Scabie - NA
Glasshouse Pharmaceuticals Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.The diagnosis of scabies as demonstrated by presence of eggs, larva, mites/mite products or fecal pellets by dermatoscopy/microscopy of skin scraping.
- •2.Presence of At least Three of the following clinical criteria
- •(a) demonstration of burrow;
- •(b) presence of scabetic lesions at the classical sites;
- •(c) nocturnal pruritus;
- •(d) Family history of similar illness.
- •3.Willing to refrain from use of other topical medications or anti-scabetic agents during the 4 week study period.
- •4.No history of chronic or recurrent dermatological disease.
- •5.If female of childbearing potential, willing to use an acceptable form of birth control [Intrauterine device in place or Oral contraceptives for at least 2 months prior to the start of the study and remaining in place during the study period, or Barrier methods containing or used in conjunction with a spermicidal agent, or Practicing sexual abstinence throughout the course of the study] during the study.
排除标准
- •1.Pregnant or lactating women or women of child bearing potential planning to become pregnant during the study period.
- •2.Subjects with known hypersensitivity to study drugs or any of its components.
- •3.Subjects with a history of treatment with any anti-scabetic or topical steroid in the previous 4 weeks.
- •4. Subjects with signs of systemic infections; or scabies with atypical presentations like crusted scabies or scabies incognito.
- •5. Subjects with severe cutaneous bacterial or fungal infections requiring therapy (including systemic and topical antibiotics).
- •6. Use of prohibited medications:
- •(a) Any anti-scabetic agent
- •(b) Topical or oral scabicidal/antiparasitic treatment including:
- •Permethrin (except study medication), benzyl alcohol, benzyl benzoate,
- •lindane, crotamiton, malathion, ivermectin, precipitated sulfur,
- •albendazole, keratolytic cream, tea tree oil, or oil of the leaves of
- •Lippia multiflora Moldenke within 28 days of baseline visit.
- •(c) Systemic corticosteroids (including inhaled steroids) taken within 14
- •days of baseline visit.
- •(d) Topical corticosteroids including hydrocortisone taken within 24 hours
- •of baseline visit.
- •(e) Topical antipruritics, including antihistamines within 24 hours of any
- •study visits.
- •(f) Oral antihistamine including diphenhydramine taken within 24 hours of
- •any study visits.
- •(g) Topical antibiotics including mupirocin taken within 24 hours of any
- •study visits.
- •7. Subjects with heavily crusted or nodular lesions, secondary infection or eczematization and coexisting dermatological disease that could interfere with the diagnosis and subsequent monitoring of scabies.
- •8. History of any significant cardiovascular, hepatic, renal, pulmonary,haematologic, gastrointestinal, endocrine, immunologic, musculoskeletal psychiatric disease, or malignancies which in the opinion of the investigator, may compromise subject safety.
- •9. History of uncontrolled diabetes mellitus, hypertension (systolic BP more than or equal to 150 mmHg/diastolic BP more than or equal to 100 mmHg), or chronic infectious diseases.
- •10.Subjects consuming tobacco in any form, alcohol, or any substance of abuse.
- •11.Known/suspected immune compromised individuals.
- •12.Participation in any other clinical study within 30 days prior to screening.
- •13.Any reason which, in the opinion of the Principal Investigator or Co- Investigator, would prevent the subject from safely participating in the study.
研究者
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