UVB-induced skin inflammation Inflammation of the skin due to UV-B radiation
Conditions
Interventions
UV-B irradiation is applied to six defined 10×10 mm areas on the back. Broad band UVB (290-320 nm) and narrowband (NB) UVB (310-315 nm) phototherapy is commonly used to treat certain skin conditions s
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Healthy male and female participants, 18 to 45 years of age, inclusive at screening. 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, blood serology and urinalysis. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy participantsBody mass index (BMI) between 18 and 30 kg/m2 and a minimum weight of 50 kg, inclusiveFitzpatrick skin type I-III (Caucasian). To minimize the risk of post-inflammatory hyperpigmentation only Fitzpatrick skin types I-III are includedWomen of childbearing potential must use effective contraception for the full duration of the study and be willing and able to continue contraception until the follow-up visit. Women of childbearing potential are defined as all women physiologically capable of becoming pregnant, unless they meet one of the following conditions:Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 weeks after surgical bilateral oophorectomy with or without hysterectomy;post-hysterectomy.Has the ability to communicate well with the investigator in the Dutch language, is able and willing to give written informed consent prior to any study-mandated procedure and to comply with the study restrictions
Exclusion criteria
Exclusion criteria: Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the participant in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the investigator to have no clinical relevanceClinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy participants.Use of immunosuppressive or immunomodulatory medication within 30 days prior to enrolment or planned use during the course of the studyUse of topical medication (prescription or over-the-counter [OTC]) within 30 days of UVB exposure on Day 1, or less than 5 half-lives (whichever is longer) in local treatment area. The treatment area is the backUse of any prescription or OTC medications within 14 days or 5 half-lives (whichever is longer) prior to UVB administration (on Day 1), unless, in the opinion of the investigator, the medication will not interfere with the study procedures or compromise safety. Exception is made for contraceptives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bulk RNA sequencing of skin punch biopsy lysates, including transcripts related toimmune cell markers cytokines/chemokinescGAS-STING pathway DNA damage response, senescence and apoptosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Olink proteomics from skin biopsy lysatesImmunofluorescence (IF) staining of skin biopsies, including for markers related to DNA damage, senescence and apoptosisImaging and biophysical parameters | — |
Countries
Netherlands
Contacts
Public ContactM. Moerland
Centre for Human Drug Research
Outcome results
None listed