EUCTR2016-003501-33-AT进行中（未招募）1 期
A prospective, single center, randomized, double-blind, placebo controlled study in two phases to evaluate the safety and efficacy of ATx201 as a topical antibiotic agent - DECOLAD
AntibioTx ApS0 个研究点目标入组 76 人开始时间: 2016年10月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 76
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
- •General inclusion criteria:
- •- Signed and dated informed consent has been obtained
- •- Age 18 – 70 years
- •- Male or female
- •- Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior trial treatment
- •- Female subjects of childbearing potential must be willing to use effective contraceptive at trial entry until completion
- •- Male subjects must agree to use adequate contraception for the duration of the trial
- •Additional inclusion criteria for Phase II of the study:
- •- Localized disease where two individual lesions each covering an area between 10-200 cm2 and where each individual lesion has an investigator global assessment (IGA) score between 1-4 and is colonized by S. aureus with at least 1,000 cfu/cm2.
- •- Additional localized lesion of area between 10-200 cm2 and where the individual lesion has an investigators global assessment (IGA) score between 1-4.
- •Are the trial subjects under 18? no
- •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 66
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •General exclusion criteria
- •- Clinically relevant abnormalities in the laboratory testing, vital signs, ECG (Phase I only) or physical examination unless considered clinically irrelevant for the scope of the trial by the Investigator
- •- Presence of any skin condition (scars, tattoos,…) that would interfere with the placement of study medication
- •- History of irritation to topical products
- •- Current acute or chronic disease unless considered clinically irrelevant for the scope of the trial by the Investigator
- •- Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin (particularly at the site of drug application), haematological, endocrine or neurological diseases that may interfere with the aim of the study
- •- Positive HIV serology or evidence of active hepatitis
- •- Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drugs (test, reference)
- •- History of drug or alcohol abuse (>2 drinks/day, defined according to USDA Dietary Guidelines 2005)
- •- Blood donations during 6 weeks prior to this study or planned within 6 weeks after the last blood withdrawal
- •- Subject considered unable or unlikely (per Investigator judgment) to comply with safety and PK profiling requirements (follow-up visits)
- •- Subjects who are pregnant (as determined by a positive pregnancy test at the screening visit) or lactating
- •- Participation in another clinical trial with an investigational drug within 4 weeks before Screening
- •Additional exclusion criteria for Phase I of the study:
- •- Regular use of medications unless considered clinically irrelevant by the Investigator
- •- Use of any dermatological drug therapy on the arms within 14 days before day 1 of this study
- •Additional exclusion criteria for Phase II of the study:
- •- Treatment with antibiotics (systemic or topical) within the past 2 months taken for systemic application, and four weeks use of topical antibiotics prior entering the study, and use of those during the study
- •- Treatment with cyclosporins within the last four weeks, use of methotrexate or mycophenolate mofetil within the last eight weeks, and biologicals within 5 times the biological half life prior to entering the study.
- •- Treatment with topical (dermatological) steroids and calcineurin inhibitors 1 week prior to start of treatment and during the study
- •- Treatment with systemic steroids within the past month and during the study
- •- Use of disinfectant soaps within 1 week before screening and during the study treatment period
研究者
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