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
- Conditions
- Blood cancer affecting the skin10014982
- Registration Number
- NL-OMON52201
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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
visit.
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
visit day.
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
screening:
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
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
analogs
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method