CompletedNot Applicable

Deep Phenotyping of Cutaneous T Cell Lymphoma, Type Mycosis Fungoides

Netherlands32 participantsStarted 2021-12-07

Plain-language summary

Mycosis fungoides (MF) is an ultra-orphan disease of which the etiology remains unknown. MF is diagnosed by correlating clinical appearance with histopathological analysis of often multiple invasive skin punch biopsies. To move patient care and the development of novel treatments for MF forward, objective, sensitive and reliable tools that are preferably non-invasive are desired. Therefore, the objective of the current study is to phenotype the early stages of mycosis fungoides in detail and to assess the response of chlormethine (CL) gel monotherapy. With this approach the investigators aim to detect novel biomarkers and to establish methodologies for the (non-)invasive monitoring of MF.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed informed consent prior to any study-mandated procedure;
✓. 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;
✓. Body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m2; during COVID-19 pandemic only ≥ 18.0 and ≤ 33.0 kg/m2;
✓. No clinically significant skin disease as judged by the investigator;
✓. No history of hypertrophic scarring or keloid;
✓. Subject is willing to refrain from extensively washing (including bathing, swimming, showering and excessive sweating) the skin 4 hours before every study visit;
✓. 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;
✓. 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;

What they're measuring

Composite Assessment of Index Lesions Disease Severity Score (CAILS)

Timeframe: from day -42 to day 155

Modified Severity Weighted Assessment Tool (mSWAT)

Timeframe: from day -42 to day 155

Objective Response Rate (ORR)

Timeframe: from day 43 to day 155

SKINDEX-29: Quality of life (QoL)

Timeframe: from day 0 to day 155

Treatment Satisfaction Questionnaire for Medication (TSQM)

Timeframe: from day 43 to day 155

Patient reported outcomes

Timeframe: from day 0 to day 155

Erythema measurement of the skin

Timeframe: from day 0 to day 155

3D Multispectral imaging

Timeframe: from day 0 to day 155

Trial details

NCT IDNCT05303480

SponsorCentre for Human Drug Research, Netherlands

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-08

View on ClinicalTrials.gov More Mycosis Fungoides trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed informed consent prior to any study-mandated procedure;
✓. 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;
✓. Body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m2; during COVID-19 pandemic only ≥ 18.0 and ≤ 33.0 kg/m2;
✓. No clinically significant skin disease as judged by the investigator;
✓. No history of hypertrophic scarring or keloid;
✓. Subject is willing to refrain from extensively washing (including bathing, swimming, showering and excessive sweating) the skin 4 hours before every study visit;
✓. 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;
✓. 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;

What they're measuring

Composite Assessment of Index Lesions Disease Severity Score (CAILS)

Timeframe: from day -42 to day 155

Modified Severity Weighted Assessment Tool (mSWAT)

Timeframe: from day -42 to day 155

Objective Response Rate (ORR)

Timeframe: from day 43 to day 155

SKINDEX-29: Quality of life (QoL)

Timeframe: from day 0 to day 155

Treatment Satisfaction Questionnaire for Medication (TSQM)

Timeframe: from day 43 to day 155

Patient reported outcomes

Timeframe: from day 0 to day 155

Erythema measurement of the skin

Timeframe: from day 0 to day 155

3D Multispectral imaging

Timeframe: from day 0 to day 155

Deep Phenotyping of Cutaneous T Cell Lymphoma, Type Mycosis Fungoides

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Deep Phenotyping of Cutaneous T Cell Lymphoma, Type Mycosis Fungoides

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria