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.
- Conditions
- cutaneous lupus erythematosuslupus affecting the skin10014982
- Registration Number
- NL-OMON56266
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
Eligible healthy volunteers must meet all the following inclusion criteria at
screening:
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.
6. No history of hypertrophic scarring or keloid.
7. Subject is willing to refrain from application of any topical product (e.g.,
ointments, cream or washing lotions) on the skin 24 hours prior to every study
visit day.
8. Subject is willing to refrain from any direct sun contact to the area being
challenged (back) for the duration of the study.
9. Subject has the ability to communicate well with the investigator in the
Dutch language and is willing to comply with the study requirements.
Eligible CLE patients must meet all the following inclusion criteria at
screening:
1. Signed informed consent prior to any study-mandated procedure.
2. Male or female CLE patients, 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
investigators.
3. Body mass index (BMI) > 18.0 and < 35.0 kg/m2.
4. Fitzpatrick skin type I-III (Caucasian).
5. Patient has the ability to communicate well with the investigator in the
Dutch language and is willing to comply with the study requirements.
6. Subject is willing to refrain from application of any topical product (e.g.,
ointments, cream or washing lotions) on the skin 24 hours prior to every study
visit day.
7. Subject is willing to refrain from any direct sun contact to the area being
challenged (back) for the duration of the study
8. Participants must have a diagnosis of CLE that fulfils the following:
* Confirmed diagnosis by clinicopathological correlation.
* Receiving one of the following treatments for CLE (stable for a
minimum of 8 weeks):
* None
* Hydroxychloroquine
* Methotrexate
* Topical corticosteroids (for the target lesion there will be a wash
out of 2 weeks before the first challenge period)
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,
melanoma);
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).
5. Antibiotic use, operation, or intervention by surgeon/dentist within one
month before Day 1.
6. Positive hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV ab),
or human immunodeficiency virus antibody (HIB ab) at screening.
7. Participation in an investigational drug study within 3 months prior to
screening or more than 4 times a year.
8. Loss or donation of blood over 500mL within three months prior to
screening.
9. The use of any medication within 28 days prior to Day 1 (apart from the
allowed CLE-medication in patients), if the investigator judges it may
interfere with the study objectives.
10. History of alcohol abuse or consumption exceeding 5 standard drinks per day
on average within 3 months of screening. Alcohol consumption will be prohibited
from at least 24 hours preceding each study visit.
11. Positive urine test for drugs or history of drug abuse at screening. Urine
drug test may be repeated at the discretion of the investigator.
12. Pregnant, a positive pregnancy test, intending to become pregnant during
the study conduct, or breastfeeding.
13. (A history of) any clinically significant medical condition, factor or
abnormality that might interfere with study conduct or interpretation, as
judged by the investigator.
14. A minimal erythema dose (MED) higher than 355 mJ/cm2 at screening.
15. Any active or chronic and/or uncontrolled condition that, in the opinion of
the investigator, may influence study conduct or interpretation.
Eligible CLE patients must meet none of the abovementioned and following
exclusion criteria at screening:
1. Presence of a relevant skin infection or disease in the target areas other
than the observational disease (CLE), inclusively, but not limited to atopic
dermatitis, psoriasis vulgaris and dermatomycosis.
2. Having received treatments for CLE or any other disease within the following
intervals prior to Day 1:
a. < 2 weeks for topical treatment, e.g., corticosteroids at target
area(s).
b. < 6 weeks for systemic therapy with immunosuppressive agents (other
than hydroxychloroquine).
c. < 12 weeks for biologics.
d. < 8 weeks procedure or surgery in or close to the target areas.
e. < 3 months for chemotherapeutical treatment.
3. Low complement (C3 and/or C4) levels at screening (< ULN).
4. Positive ANA and anti-dsDNA and/or anti-SM antibodies at screening.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method