Clinical trial · Interventional
Defining the Role of the Skin Microbiome in Immune-related Adverse Events
Defining the Role of the Skin Microbiome in Vitiligo and Immune-related Adverse Events in Advanced Melanoma Patients Treated With Anti-PD1
NCT04734704CI-TRIAL-00115582SKINBIOTAterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): target number of patients not reached and disabling team changes
Summary
Brief summary (as posted)
The skin microbiome has been implicated in several cutaneous autoimmune pathologies such as psoriasis and atopic dermatitis. However, its role in vitiligo and vitiligo lesions occuring in patients receiving anti-PD-1 for metastatic melanoma
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Melanoma | Cutaneous Melanoma | ALIAS | 0.90 |
| Vitiligo | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| skin swabs at lesional and non-lesional sites | Procedure | — | UNRESOLVED |
| skin swabs on skin | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- vitiligo patients
- description
- Adult patients diagnosed with Vitiligo according to usual criteria
- interventionNames
- Procedure: skin swabs at lesional and non-lesional sites
- type
- EXPERIMENTAL
- label
- metastatic melanoma patients under anti-PD-1 who did not develop cutaneous irAEs
- description
- metastatic melanoma patients under anti-PD-1 who did not develop Cutaneous Immune-Related Adverse Events (cutaneous irAEs).
- interventionNames
- Procedure: skin swabs on skin
- type
- EXPERIMENTAL
- label
- Metastatic melanoma patients under anti-PD-1 who developed vitiligo lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients diagnosed with Vitiligo according to usual criteria. * Adult patients with metastatic melanoma, under anti-PD-1 who developed vitiligo * Adult patients with metastatic melanoma who did not develop Immune related adverse events under anti-PD-1 * Adult patients with metastatic melanoma who developed vitiligo under anti-PD-1 and discontinued the treatment * Free, informed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research). Exclusion Criteria: * Patients under 18 years old. * No treatment for vitiligo in the past 4 weeks * Patients under legal protection or unable to express their consent. * Patients not affiliated to a health insurance system. * Patients deprived of liberty by judiciary or administrative decision or hospitalized without consent or admitted in a sanitary or social institution for another reason than research.
References
Publications (0)
Data not yet available
No reference posted for this study.