A study to investigate the effect of heat on skin suctions blisters in a model wherein inflammation of the skin is induced by lipopolysaccharide in healthy volunteers

Not Applicable

Completed

• Conditions: Influence of heat on skin suction blisters in a lipopolysaccharide (LPS) challenge model in healthy volunteers; Not Applicable

• Registration Number: ISRCTN11296911
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-02-22
• Study Start: 2022-06-17
• Last Update Posted: 2022-06-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Healthy male and female subjects, 18 to 45 years of age, inclusive. Healthy status is defined by the 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

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. Or the donation of plasma within 14 days 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