Investigating anti-inflammatory effects of topical antibiotics in an LPS skin challenge model
- Conditions
- Skin inlammation10014982
- Registration Number
- NL-OMON46315
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Healthy male 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 50 kg;
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.
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 (including tattoos) 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. Tanning due to sunbathing, 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Tolerability / safety endpoints<br /><br>*Monitoring Adverse events (AEs)<br /><br>* Monitoring BP, HR and T<br /><br>*Local tolerance (Numeric Rating Scale (NRS) pruritus and pain)<br /><br>*Circulating cytokines (TNF*, IL-6, IL-8, IL-1*), and leukocytes<br /><br><br /><br>Pharmacodynamic endpoints<br /><br>Non-invasive measures:<br /><br>*Perfusion by Laser speckle contrast imaging (LSCI)<br /><br>*Erythema by Antera 3D camera / 2D camera<br /><br>*Erythema by clinical evaluation (erythema grading scale)<br /><br>*Temperature by thermography<br /><br>*Skin microbiome<br /><br><br /><br>Invasive measures:<br /><br>Suction blister exudates:<br /><br>o Cytokines and chemokines (protein, TBD)<br /><br>o Flow cytometry:<br /><br>*Neutrophils<br /><br>*Monocytes/macrophages<br /><br>*CD4+ lymphocytes<br /><br>*CD8+ lymphocytes<br /><br>*CD56+ lymphocytes<br /><br>*CD1c dendritic cells</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>