EUCTR2020-002219-24-BE进行中（未招募）1 期
A Randomized, Double-Blind, Parallel Group, Equivalence, Multicenter Phase III Trial to Compare the Efficacy and Safety of Fusidic Acid Hydrophilic Cream 20 mg/g and Fucidin® Cream in the Treatment of Adult and Pediatric Subjects with Impetigo. - IMPET
Basic Pharma Technologies0 个研究点目标入组 200 人开始时间: 2020年8月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Subjects having a clinical diagnosis of localized impetigo contagiosa (not the extensive forms)
- •2.Skin Infection Score: more than 7 points
- •3.Subject age: =18 months of age
- •4.Subject (and/or parent or legal guardian) is willing to comply with the protocol, remain available for follow up visits, and provide informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •If a subject meets one of the stated exclusion criteria, he/she cannot participate in this study. The exclusion criteria will apply to all subjects at all study visits.
- •1.Subjects for whom no signed and dated informed consent is obtained
- •2.Subjects whose temperature is >38.5°C (higher than low grade fever)
- •3.Subjects who have extensive forms of impetigo, defined as:
- •More than 10 lesions
- •Total affected area >100 cm2
- •The surrounding redness extends >2 cm from the edge of the lesions
- •4.Subjects with secondary impetigo, where the infection is secondary to some other underlying skin disease
- •5.Subjects that have used other medications or treatments prior to enrollment in the study, including:
- •For 24 hours prior to entry: subjects should not have been treated with topical steroids, topical retinoids, topical antibiotics or other ingredients considered as antibacterial, such as salicylic acid
- •For 1 week prior to entry: subjects should not have utilized medicated shampoos or medicated cleansers of any type. Non-medicated cleansers and emollients are permitted at the discretion of the investigator
- •For 1 month prior to entry: subjects should not have been treated with UV-lamp irradiation, oral antibiotics or parenteral corticosteroids
- •6.Subjects who have other significant skin infections, diseases or disorders of the skin, including:
- •Systemic erythema (skin redness), not related to impetigo
- •Allergic rashes
- •Viral or fungal infections of the skin
- •Contact dermatitis
- •Herpes simplex virus
- •Discoid lupus
- •Necrotizing fasciitis
- •Other significant diseases of the skin
- •7.Subjects with a recent history of other severe systemic diseases within 3 months prior to enrollment, including:
- •Severely impaired liver or renal function
- •Severe cardiovascular disease
- •Severe neurological disease
- •Immunocompromised patient
- •Severe disease that may interfere with the study evaluations
- •8.Subjects with a serious disease that potentially could be life threatening (including laboratory testing results) or that may interfere with the objective of the study, according to the opinion of the investigator
- •9.Subjects requiring any significant concomitant medication that may affect the results of the study
- •10.Subjects with sunburn and those who may experience considerable exposure to sunlight during the study period (including UV lamps)
- •11.Subjects who have a history of hypersensitivity to fusidic acid or to any other component of the study medication
- •12.Pregnant subjects, female subjects planning pregnancy during the study and breast- feeding subjects
- •13.Subjects that participated in another clinical study within 3 months prior to the enrolment
- •14.Subjects who are considered as unreliable or unlikely to be available during the study
- •15.Subjects that previously participated in the present trial
研究者
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