Clinical trial · Observational
Skin Barrier and Microbiome of CTCL Patients
A Single-centre, Exploratory Study to Characterise the Skin Barrier and Microbiome of Patients With Cutaneous T-cell Lymphoma (CTCL)
NCT05827107CI-TRIAL-00091021completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this study is to investigate the microbiome composition of the nares, non-lesional skin and patches, plaques and tumours in lesional skin of CTCL patients, including all stages of the disease, and to correlate microbiome (including S. aureus presence) and disease severity from CTCL patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, T-Cell, Cutaneous | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Microbiome composition of skin lesions (target lesions, nares and non-lesional skin)
- timeFrame
- baseline visit
- measure
- Bacterial colonisation via semi-quantitative bacterial culture samples for S. aureus
- timeFrame
- baseline visit
- measure
- Correlation of microbiome and culture results with clinical CTCL symptoms and their intra- and inter-patient variability.
- timeFrame
- baseline visit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able to understand and provide a written informed consent prior to any study procedures. 2. Male or female subjects, 18 years or older. 3. A confirmed diagnosis of CTCL (MF type or SS type) and stage classification via histology or clinico-histopathological correlation. 4. For the stage IA-IIA CTCL patients: at least one patch and/or one plaque lesion are present, with at least one dimension with a diameter of ≥3 cm. For the stage IIB and higher classified CTCL patients: at least one tumour is present, with at least one dimension with a diameter of ≥1.5 cm. Exclusion Criteria: 1. Use of topical antibiotic (on selected target lesions) and/or oral antibiotic therapy in the previous 14 days before the visit. 2. Clinically significant skin disease on the selected lesions, other than CTCL or CTCL associated secondary impetiginisation, as judged by the investigator. 3. Ongoing active skin infection, other than secondary impetiginized CTCL lesions. 4. Treatment of selected target CTCL lesions with radiotherapy within 8 weeks prior to Day 1. 5. Any other clinical condition that may preclude participation in the study as judged by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.