A randomized, evaluator-blinded, vehicle-controlled study to explore the pharmacodynamic effects of omiganan and omiganan in combination with imiquimod in healthy volunteers.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

1. Healthy male and 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, haematology, blood chemistry, 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. Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.
5. Able to participate and willing to give written informed consent and to comply with the study restrictions.

Exclusion Criteria

1. Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients
2. Family history of psoriasis
3. History of pathological scar formation (keloid, hypertrophic scar)
4. Have any current and / or recurrent pathologically, clinical significant relevant skin condition.
5. Previous use of imiquimod/ resiquimod/ gardiquimod
6. Known hypersensitivity to the (non)investigational drug, comparative drug, drugs of the same class, or any of their excipients.
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. Use of topical medication (prescription or over-the-counter [OTC]) within 30 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area
10. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment.
11. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
12. Loss or donation of blood over 500 mL within three months prior to screening
13. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamic effects of this study will be assessed at the time points<br /><br>indicated in the Visit and Assessment Schedule (Table 3) by:<br /><br>- Local (biopsy) biomarkers ((including but not limited to IL-8, IFN-, IFN-,<br /><br>IFN-, MXA, MX1, IL-6, IL-10, CCL20 and HBD-2)<br /><br>- Histology (HE)<br /><br>- Immunohistochemistry (CD1a, HLADR, CD8+, CD4+, CD14+, CD11c)<br /><br>- Transdermal Analysis Patch (IL-8, IFN-, IL-6, IL-10, CCL20 and HBD-2)<br /><br>- Perfusion by Laser speckle contrast imaging (LSCI)<br /><br>- Colorimetric<br /><br>- Clinical evaluation (erythema grading scale)<br /><br>- Photography (total body imaging); erythema index<br /><br>- Thermography<br /><br>- Skin microbiome</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Tolerability / safety endpoints<br /><br><br /><br>- Vital signs<br /><br>- 12-leads ECGs<br /><br>- Local tolerance (Visual Analogue Scale (NRS) pruritus and pain)<br /><br>- Circulating cytokines (IFN-, IFN-)</p><br>