EUCTR2004-004439-70-DE进行中（未招募）不适用
A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo
GlaxSmithKline Research & Development0 个研究点目标入组 520 人开始时间: 2005年2月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 520
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
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •1.The subject is greater than or equal to 9 months of age.
- •2.The subject has a clinical diagnosis of primary impetigo (bullous and non-bullous) defined as follows:
- •A lesion or a group of lesions characterised by red spots or blisters without crusts which later progress to lesions which ooze and form yellow or honey-coloured crusts surrounded by an erythematous margin.
- •3.The subject has no more than 10 discrete localised impetigo lesions suitable for topical treatment.
- •4.The infected lesion(s) should not exceed 100 cm2 in area with surrounding erythema not extending more than 2 cm from the edge of any lesion or up to a maximum of 2% body surface area for subjects < 18 years of age. If a subject has multiple lesions the total area should not exceed a total of 100 cm2 in area.
- •5.Female subjects of child-bearing potential have had a negative urine pregnancy test prior to enrolment.
- •6.The subject has a Skin Infection Rating Scale Score of at least 8
- •7.The subject is willing and able to comply with the study protocol.
- •8.The subject has given written informed, dated consent to participate in the study.
- •For paediatric subjects under the legal age of consent (dependent on local country practice):
- •9.The parent/legal guardian is willing to comply with the protocol.
- •10.The child has given their assent to participate in the study. (This is only required if the child is of an age to assent to enroll in the study; age of assent to be determined by IRB/IEC, or to be consistent with local legal requirements).
- •11.The parent/legal guardian has given written, informed, dated consent for the subject to participate in the study.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •1.The subject has demonstrated a previous hypersensitivity reaction to sodium fusidate or to any component of the ointment (refer to the prescribing information for composition of the sodium fusidate ointment), or the subject has demonstrated a previous hypersensitivity reaction to pleuromutilin or any component of the ointment (refer to the Investigator Brochure for composition of SB-275833 ointment).
- •2.The subject has an underlying skin disease (e.g., pre-existing eczematous dermatitis) or skin trauma, with clinical evidence of secondary infection.
- •3.The subject has signs and symptoms of systemic infection (such as fever, defined as an oral temperature greater than 101° F or 38.3° C).
- •4.The subject has a bacterial skin infection which, due to depth or severity, in the opinion of the investigator, cannot be appropriately treated by a topical antibiotic. Examples include extensive cellulitis, furunculosis and abscess.
- •5.The subject has received a systemic antibacterial, steroid, or has applied any topical therapeutic agent (including glucocorticoid steroids, antibacterials and antifungals) directly to the impetigo lesion(s), less than 24 hours prior to study entry.
- •6.The subject has a serious underlying disease that could be imminently life threatening.
- •7.The subject is pregnant, breast-feeding or planning a pregnancy during the study.
- •8.The subject has used an investigational drug within 30 days prior to entering the study.
- •9.The subject has been previously enrolled in this study or in any other study involving SB-275833.
- •During the study period, the infected lesion(s) may only be treated with the topical agent to which the subject was randomised, i.e. 1% SB-275833 ointment or 2% sodium fusidate ointment.
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