Comparison of skin suction blister method with or without heat plate in a LPS challenge model in healthy volunteers

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

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, hematology, blood chemistry,
coagulation, blood serology and urinalysis;
2. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and with a minimum
weight of 50 kg;
3. Fitzpatrick skin type I-III (Caucasian);
4. Subjects of childbearing potential must use effective contraception for the
duration of the study;
5. Able and willing to give written informed consent and to comply with the
study restrictions.

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 (medical) condition that would, in the opinion of the investigator,
potentially compromise the safety or compliance of the patient or may preclude
the patient*s successful completion of the clinical trial;
3. Any vaccination within the last month; COVID-19 vaccination is allowed up
until 2 weeks before study day 1;
4. Have any current and / or recurrent pathologically, clinical significant
skin condition at the treatment area (i.e. atopic dermatitis); including
tattoos;
5. Hypersensitivity for dermatological marker at screening;
6. Requirement of immunosuppressive or immunomodulatory medication within 30
days prior to enrolment or planned to use during the course of the study;
7. Use of topical medication (prescription or over-the-counter [OTC]) within 30
days prior to day 1, or less than 5 half-lives (whichever is longer) on lower
arms;
8. Excessive sun exposure or a tanning booth within 3 weeks of enrolment;
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;
11. Volunteers with clinically relevant infections;
12. Current nicotine use in excess of 5 cigarettes per day or unable to abstain
from smoking during the course of the study (from screening till end of study);
13. History of or current drug or substance abuse considered significant by PI
(or medically qualified designee), including a positive urine drug screen;
14. Covid-19 infection (with positive test result) within the last 4 weeks.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Clinical/biophysical measures: blister induction time, 2D and 3D images,<br /><br>blister volume, erythema by clinical evaluation (erythema grading scale)<br /><br>* Cellular and cytokine responses in blister exudate:<br /><br>o Cytokines and chemokines<br /><br>o Flow cytometry, immune cells including but not limited to:<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>* NRS pain score<br /><br>* Blood flow as measured with basal flow through laser speckle contrast imaging<br /><br>(LSCI)<br /><br>* Microcirculation as measured by side-stream darkfield microscopy (SDFM). The<br /><br>following parameters will be analyzed:<br /><br>o Number of vessels, vessel density, perfused number of vessels, perfused<br /><br>vessel density<br /><br>* Qualitative assessment of dermo-epidermal layer<br /><br>* Transepidermal water loss</p><br>