NL-OMON52201已完成不适用
An exploratory, single-center, two-part study to describe mycosis fungoides characteristics and explore novel biomarkers with a multi-modal patient profiling approach by comparing MF patients to healthy volunteers - Deep phenotyping of CTCL, type mycosis fungoides
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy volunteers must meet all of the following inclusion criteria:
- •1. Signed informed consent prior to any study-mandated procedure;
- •2. Male or female subjects, 18 to 75 years of age, inclusive at screening; 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 <= 40.0 kg/m2; during COVID-19 pandemic only
- •>= 18.0 and <= 33.0 kg/m2
- •4. No clinically significant skin disease as judged by the investigator
- •5. No history of hypertrophic scarring or keloid.
- •6. Subject is willing to refrain from extensively washing (including bathing,
- •swimming, showering and excessive sweating) the skin 4 hours before every study
- •7. Subject is willing and able to washout and withhold any topical treatment
- •(prescription and over the counter products) in the treatment area (if possible
- •matched location to most common location of target lesions of the MF group, and
- •otherwise 100cm2 on the lower back) for 2 weeks prior to Day 1.
- •8. Subject is willing to refrain from application of any topical product (e.g.
- •ointments, crème or washing lotions) on the skin 24 hours prior to every study
- •9. Subject is willing and able to washout (topical and oral) antibiotic therapy
- •for 14 days prior to Day 1.
- •10. Subject is willing to use effective contraception from screening until EOS
- •if subject is male or women of childbearing potential
- •11. Subject has the ability to communicate well with the investigator in the
- •Dutch language and is willing to comply with the study restrictions.
- •Eligible MF patients must meet all of the following inclusion criteria at
- •1. Signed informed consent prior to any study-mandated procedure;
- •2. Male or female subjects, 18 to 75 years of age, inclusive at screening; 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 <= 40.0 kg/m2; during COVID-19 pandemic only
- •>= 18.0 and <= 33.0 kg/m2.
- •4. At least one patch and/or plaque lesion present, with at least one dimension
- •with a diameter of >= 6cm.
- •5. Confirmed MF-diagnosis (stage 1a/1b) by histology (or
- •clinico-histopathological correlation) within the last 10 years.
- •6. Willing and able to washout any topical treatment for MF (at least 2 weeks)
- •and any systemic treatment for MF (at least 4 weeks) prior to Day 1, resulting
- •in a washout of 8 weeks for topical treatment and 10 weeks for disease-related
- •systemic treatment prior to the first dosing day (day 43).
- •7. No previous use of CL gel (Ledaga) in the past two years.
- •8. Subject is willing and able to washout (topical and oral) antibiotic therapy
- •for 14 days prior to Day 1.
- •9. Subject is willing to refrain from extensively washing (including bathing,
- •swimming, showering and excessive sweating) the skin 6 hours before every study
- •visit day and up to 2 hours after application of the treatment
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) that may
- •interfere with study objectives, in the opinion of the investigator.
- •2. The use of systemic antibiotic therapy for >2 months the past 12 months.
- •3. The use of any oral/systemic medication (e.g. immunomodulatory,
- •immunosuppressive) within 28 days prior to Day 1, if the investigator judges
- •that it may interfere with the study objectives.
- •4. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV ab),
- •or human immunodeficiency virus antibody (HIV ab) at screening;
- •5. Participation in an investigational drug study within 3 months prior to
- •screening or more than 4 times a year.
- •6. Loss or donation of blood over 500mL within three months prior to screening.
- •7. History of alcohol 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.
- •8. Positive urine test for drugs or history of abuse at screening or pre-dose.
- •Urine drug test may be repeated at the discretion of the investigator;
- •9. Pregnant, a positive pregnancy test, intending to become pregnant, or
- •breastfeeding;
- •10. Any other known factor, condition, or disease that might interfere with
- •study conduct or interpretation.
- •Eligible MF-patients must meet none of the abovementioned and following
- •exclusion criteria at screening:
- •1. Have any current relevant skin infections/disease in the treatment area
- •other than the observational disease (mycosis fungoides), inclusively, but not
- •limited to atopic dermatitis, psoriasis vulgaris, dermatomycosis and other skin
- •malignancies.
- •2. Having received treatments for MF or any other disease within the following
- •intervals prior to the start of the study (The use of topical emollients is
- •allowed during the study. For target lesions it is allowed up to 24h before
- •every study visit day):
- •a. < 2 weeks for topical treatment, e.g. corticosteroids, retinoids, vitamin D
- •b. <4 weeks for phototherapy, e.g. UVB, PUVA, PDT
- •c. <4 weeks for non-biologic systemic treatment, e.g. retinoids, methotrexate
- •d. <6 weeks for peginterferon alfa-2a
- •e. <8 weeks for radiotherapy or surgery in the treatment area
- •f. <3 months for any systemic chemotherapeutical treatment
- •3. Known hypersensitivity to chlormethine gel or its excipients
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