Investigating anti-inflammatory effects of topical antibiotics in an LPS skin challenge model - Intradermal LPS and antibiotics

Centre for Human Drug Research0 个研究点目标入组 30 人开始时间: 2018年11月1日最近更新: 2019年11月25日

适应症

试验速览

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•1. Healthy male or female subjects, 18 to 45 years of age, inclusive. Healthy status is defined
•by absence of evidence of any active or chronic disease following a detailed medical and
•surgical history, a complete physical examination including vital signs, 12-lead ECG,
•hematology, blood chemistry, blood serology and urinalysis;
•2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of
•3. Fitzpatrick skin type I-III (Caucasian);
•4. Able and willing to give written informed consent and to comply with the study restrictions.
•5. Able to work with the Ediary App
•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 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Any disease associated with immune system impairment, including auto-immune diseases,
•HIV and transplantation patients;
•2. Type 1 or type 2 diabetes mellitus;
•3. Any vaccination within the last 3 months;
•4. Family history of psoriasis;
•5. History of pathological scar formation (keloid, hypertrophic scar);
•6. Have any current and / or recurrent pathologically, clinical significant skin condition at the
•treatment area (i.e. atopic dermatitis);
•7. Hypersensitivity for dermatological marker at screening;
•8. Requirement of immunosuppressive or immunomodulatory medication within 30 days prior
•to enrollment or planned to use during the course of the study;
•9. Excessive sun exposure or a tanning booth within 3 weeks of enrollment;
•10. Participation in an investigational drug or device study within 3 months prior to screening or
•more than 4 times a year;
•11. Loss or donation of blood over 500 mL within three months prior to screening. Or the
•donation of plasma within 14 days prior to screening;
•12. Current smoker and/or regular user of other nicotine-containing products (e.g., patches);
•13. History of or current drug or substance abuse considered significant by the PI (or medically
•qualified designee), including a positive urine drug screen.

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