Skin inflammation
Conditions
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: Eligible subjects must meet none of the following exclusion criteria at screening: 1. Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients; 2. Any vaccination within the last 3 months; 3. Family history of psoriasis; 4. History of pathological scar formation (keloid, hypertrophic scar); 5. Have any current and / or recurrent pathologically, clinical significant skin condition at the treatment area (i.e. atopic dermatitis); 6. Hypersensitivity for dermatological marker at screening; 7. Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study; 8. Excessive sun exposure or a tanning booth within 3 weeks of enrollment; 9. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year; 10. 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; 11. Current smoker and/or regular user of other nicotine-containing products (e.g., patches); 12. History of or current drug or substance abuse considered significant by the PI (or medically qualified designee), including a positive urine drug screen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability / safety endpoints • Monitoring Adverse events (AEs) • Monitoring BP, HR and T • Local tolerance (Numeric Rating Scale (NRS) pruritus and pain) • Circulating cytokines (TNFa, IL-6, IL-8, IL-1β), complement activation Pharmacodynamic endpoints Non-invasive measures: • Perfusion by Laser speckle contrast imaging (LSCI) • Erythema by Antera 3D camera • Erythema by clinical evaluation (erythema grading scale) • Temperature by thermography Invasive measures: • Biopsies: o Cytokines and chemokines (mRNA, TBD) o Histology (HE) o Immunohistochemistry: - Neutrophils - Monocytes/macrophages - CD4+ lymphocytes - CD8+ lymphocytes - CD56+ lymphocytes - CD1c dendritic cells • Suction blister exudates: o Cytokines and chemokines (protein, TBD) o Flow cytometry: - Neutrophils - Monocytes/macrophages - CD4+ lymphocytes - CD8+ lymphocytes - CD56+ lymphocytes - CD1c dendritic cells | — |
Secondary
| Measure | Time frame |
|---|---|
| N.A. | — |
Countries
Netherlands
Outcome results
None listed