CTRI/2020/09/027948已完成3 期
A prospective, randomized, two-arm, activecontrolled,parallel, multicentre, non-inferiority,phase III clinical trial to assess the efficacyand safety of Amorolfine lotion 0.25% w/v ascompared to Amorolfine cream 0.25% w/w inpatients with superficial fungal infection of theskin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 284
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. Patients of either gender of 18 to 65 years of age (both inclusive)
- •2. Patients with acute symptomatic tinea corporis or tinea cruris limited to single body region and with limited involvement i.e., < 5 skin lesions with each having greatest diameter of < 5 cm
- •3. Mycological diagnosis of tinea corporis or tinea cruris confirmed by detection of fungal hyphae on a microscopic KOH test
- •4. Patients with total clinical score of at least 5
- •5. Patients willing to provide written informed consent and comply with the protocol requirements
排除标准
- •1. Patients with history of hypersensitivity to amorolfine
- •2. Patients with extensive or disseminated tinea infections
- •3. Patients with tinea infection other than tinea corporis or tinea cruris
- •4. Patients with diagnosis of tinea infection requiring systemic treatment according to the severity of lesion as judged by the investigator
- •5. Patients having skin lesions with secondary bacterial infection
- •6. Patients with other dermatological conditions which may confound the disease assessment and treatment evaluation e.g., contact dermatitis, atopic dermatitis, psoriasis, urticaria
- •7. Patients with clinically significant uncontrolled systemic diseases such as gastrointestinal, cardiovascular, renal, neurological, psychiatric, endocrine or hematological disorders or malignancy
- •8. Patients with immunosuppressive disorder e.g., HIV infection or patients on immunosuppressive medications e.g., systemic corticosteroids or cytotoxic drugs
- •9. Patients with hepatic dysfunction (serum transaminases ââ?°Â¥ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine ââ?°Â¥ 2.5 mg/dl)
- •10. Patients who have used the following medications:
- •a. Topical antifungal agent within 30 days prior to enrollment
- •b. Systemic antifungal agent within 8 weeks (8 months for oral terbinafine) prior to enrollment
- •c. Topical corticosteroid on the affected area(s) within 30 days prior to enrollment
- •d. Systemic corticosteroids within 30 days prior to enrollment
- •e. Systemic antihistamine agent within 3 days prior to enrollment
- •f. Any other topical treatment on the affected area(s) within 7 days prior to enrollment
- •11. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
- •12. Patients with history of alcohol and/or drug abuse
- •13. Participation in another clinical trial in the past 3 months prior to screening
- •14. Any other reason for which the investigator feels that the patient should not participate
研究者
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