NL-OMON56266
Recruiting
Not Applicable
A Phase 0, single-center study to characterize the response of a UV-B skin challenge on the skin of healthy volunteers and cutaneous lupus erythematosus (CLE) patients. - UV-B challenge in healthy volunteers and CLE patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- cutaneous lupus erythematosus
- Sponsor
- Centre for Human Drug Research
- Enrollment
- 16
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligible healthy volunteers must meet all the following inclusion criteria at
- •1\. Signed informed consent prior to any study\-mandated procedure.
- •2\. Male or female subjects,18\-65 years of age at the time of signing informed
- •consent; in general, stable good health as per judgement of the investigator
- •based upon the results of a medical history, physical examination, vital signs,
- •ECG, and laboratory assessments performed at screening. Repeated laboratory
- •testing may be performed at the discretion of the clinical investigator.
- •3\. Body mass index (BMI) \> 18\.0 and \< 32\.0 kg/m2\.
- •4\. Fitzpatrick skin type I\-III (Caucasian).
- •5\. No clinically significant skin disease as judged by the investigator.
Exclusion Criteria
- •Eligible healthy volunteers must meet none of the following exclusion criteria
- •at screening:
- •1\. (History of) immunological abnormality (e.g., immune suppression by
- •medication, auto\-immune disease, auto\-inflammatory disease) that may interfere
- •with study objectives, in the opinion of the investigator.
- •2\. History of skin cancer (basal cell carcinoma, squamous cell carcinoma,
- •3\. Diagnosis of systemic lupus erythematosus (SLE) according to the EULAR\-ACR
- •criteria (2019\) or substantial indication for systemic involvement.
- •4\. Have any current and/or recurrent clinically significant skin condition,
- •including tattoos, in the skin area of interest (back).
Outcomes
Primary Outcomes
Not specified
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