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Deep Phenotyping of Cutaneous T Cell Lymphoma, Type Mycosis Fungoides

NCT05303480 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-01-25

No results posted yet for this study

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.

Conditions

  • Mycosis Fungoides

Interventions

DRUG

Chlormethine

Chlormethine gel 0.016%

Sponsors & Collaborators

  • Recordati Rare Diseases

    collaborator INDUSTRY

  • Centre for Human Drug Research, Netherlands

    lead OTHER

Principal Investigators

  • Robert Rissmann, Prof. Dr. · Centre for Human Drug Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2022-12-08
Completion
2022-12-08

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05303480 on ClinicalTrials.gov