NL-OMON56266招募中不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
- •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
- •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
- •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
- •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):
- •* Hydroxychloroquine
- •* Methotrexate
- •* Topical corticosteroids (for the target lesion there will be a wash
- •out of 2 weeks before the first challenge period)
排除标准
- •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).
- •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
- •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
- •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.
研究者
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