Status:
COMPLETED
Intradermal LPS and Antibiotics
Lead Sponsor:
Centre for Human Drug Research, Netherlands
Collaborating Sponsors:
Maruho Co., Ltd.
Conditions:
Inflammation; Skin
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Erythromycin and clindamycin are believed to have anti-inflammatory aspects. This study investigates the possible anti-inflammatory effects of erythromycin and clindamycin.
Detailed Description
Convincing mechanistic reports on the immunomodulatory action of erythromycin and clindamycin are scarce, rarely based on experiments in freshly isolated human immune cells, and potentially contradict...
Eligibility Criteria
Inclusion
- 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;
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg;
- Fitzpatrick skin type I-III (Caucasian);
- Able and willing to give written informed consent and to comply with the study restrictions.
- Able to work with the eDiary app.
Exclusion
- Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients;
- Type 1 or type 2 diabetes mellitus;
- Any vaccination within the last 3 months;
- Family history of psoriasis;
- History of pathological scar formation (keloid, hypertrophic scar);
- Have any current and / or recurrent pathologically, clinical significant skin condition at the treatment area (i.e. atopic dermatitis);
- Hypersensitivity for dermatological marker at screening;
- Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study;
- Excessive sun exposure or a tanning booth within 3 weeks of enrollment;
- Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
- 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;
- Current smoker and/or regular user of other nicotine-containing products (e.g., patches);
- History of or current drug or substance abuse considered significant by the PI (or medically qualified designee), including a positive urine drug screen.
Key Trial Info
Start Date :
October 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03779360
Start Date
October 12 2018
End Date
February 23 2019
Last Update
August 3 2021
Active Locations (1)
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1
Centre for Human Drug Research
Leiden, South Holland, Netherlands, 2333 CL