VitiligoSKINBIOTANCT04734704
Defining the Role of the Skin Microbiome in Immune-related Adverse Events
A study testing skin swabs at lesional and non-lesional sites and skin swabs on skin in people with Vitiligo and Skin Melanoma, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo, Skin Melanoma
- What is being tested?
- skin swabs at lesional and non-lesional sites and skin swabs on skin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2022to 23 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Dermatologie - Hôpital Saint-André
Bordeaux, Bordeaux, 33075
About this study
Official title: Defining the Role of the Skin Microbiome in Vitiligo and Immune-related Adverse Events in Advanced Melanoma Patients Treated With Anti-PD1
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
Read the detailed description
Melanoma is the most dangerous skin cancer accounting for the highest skin cancer deaths. The prognosis for metastatic melanoma has improved considerably in recent years thanks to advances in the field of immunotherapy. The development of molecules blocking certain immunological "checkpoints" (checkpoints exerted by the CTLA-4 (Cytotoxic T lymphocytes Associated protein 4) and PD-1 (Programmed cell Death protein 1) has made it possible to obtain a significant improvement of the overall survival (OS) of patients treated for metastatic melanoma. Ipilimumab, an antibody blocking CTLA-4, is the first immunotherapy marketed, demonstrating for the first time a therapeutic response, however in a small number of patients (10 to 15%) and with significant toxicity (25% of grade 3-4). Subsequently, a second generation of more effective checkpoint blockers (30 to 40% good response) and less toxic, anti-PD-1 antibodies (pembrolizumab and nivolumab), quickly obtained a marketing authorization in the first line treatment of metastatic melanoma treatment and recently in an adjuvant situation after lymph node dissection in order to limit the risk of recurrence. However, despite these advances, a certain number of patients do not respond to treatment and it remains difficult to predict this therapeutic response. Furthermore, patients treated with ICI often experience cutaneous immune-related adverse events manifesting as skin rash, dermatitis, epidermal necrolysis, and in some cases as vitiligo like depigmentation of the skin, testifying to the development of a specific immunogenicity towards the melanocytes, cells causing melanoma, and responsible for a discoloration of the skin. Several studies have reported that a modification of certain bacteria in the digestive microbiota was predictive of the antitumor response to immunotherapy, while others were predictive of the appearance of significant autoimmune ICI-related toxicities (colitis). Several phase 1 studies have evaluated the impact of taking probiotics or fecal transplants on the tumor response of patients receiving immunotherapy for cancer (NCT 03819296; NCT03817125; NCT03643289). Thus by these new concepts, it would be interesting to assess the composition of the skin microbiota in patients treated with anti-PD-1 immunotherapy for the management of metastatic melanoma and developing during their follow-up vitiligo; predictive side effect of improved survival. These data will be compared to those obtained from patients with common vitiligo. This will be examined in patients skin swabs sampled at lesional and non-lesional sites. Functionally, we will characterize the microbial pathways using shotgun sequencing of microbial genomes and meta-transcriptomics (RNA sequencing of microbial communities of the skin).
- Conditions
- Vitiligo, Skin Melanoma
- Being tested
- skin swabs at lesional and non-lesional sites, skin swabs on skin
- Keywords
- immunotherapy, checkpoint inhibitors, vitiligo, skin microbiota, metastatic melanoma.
- Medical subject headings
- Vitiligo, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin swabs at lesional and non-lesional sitesProcedure or surgery
It will be examined in patients skin swabs sampled at lesional and non-lesional sites
skin swabs on skinProcedure or surgery
It will be examined in patients skin swabs sampled on skin
| Study group | Role | What they receive |
|---|---|---|
| vitiligo patients | Experimental | Adult patients diagnosed with Vitiligo according to usual criteria Receives: Procedure: skin swabs at lesional and non-lesional sites |
| metastatic melanoma patients under anti-PD-1 who did not develop cutaneous irAEs | Experimental | metastatic melanoma patients under anti-PD-1 who did not develop Cutaneous Immune-Related Adverse Events (cutaneous irAEs). Receives: Procedure: skin swabs on skin |
| Metastatic melanoma patients under anti-PD-1 who developed vitiligo lesions | Experimental | patients with metastatic melanoma, under anti-PD-1 who developed vitiligo lesions Receives: Procedure: skin swabs at lesional and non-lesional sites |
| metastatic melanoma patients with vitiligo lesions under anti-PD-1 who discontinued | Experimental | Metastatic melanoma who developed vitiligo lesions under anti-PD-1 who discontinued the treatment Receives: Procedure: skin swabs at lesional and non-lesional sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine skin microbiota by sequencing with vitiligo in advanced melanoma patients under immune-checkpoint inhibitors (ICI) immunotherapy.
The composition of the skin microbiota will be characterized on skin swabs using shotgun sequencing of microbial genomes and meta-transcriptomics (RNA sequencing of microbial communities of the skin).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start11 Jan 2022
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Why it stopped: target number of patients not reached and disabling team changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Monocentric (CHU de Bordeaux, Department of dermatology ), with 4 groups : * vitiligo patients * Metastatic melanoma patients receiving anti-PD-1 but without cutaneous irAEs * Metastatic melanoma patients receiving anti-PD-1 who developed vitiligo lesions * metastatic melanoma patients who developed vitiligo under anti-PD-1, who discontinued the treatment.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
- Investigators
- Julien SENESCHAL, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734704
- Sponsor's protocol ID
- CHUBX 2020/41
- Acronym
- SKINBIOTA
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2021
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Role of the Skin Microbiome in Vitiligo and Immune-related Adverse Events in Advanced Melanoma Patients Treated With Anti-PD1
- ClinicalTrials.gov ID
- NCT04734704
- Acronym / sponsor ID
- SKINBIOTA / CHUBX 2020/41
- Conditions
- Vitiligo, Skin Melanoma
- Keywords
- immunotherapy, checkpoint inhibitors, vitiligo, skin microbiota, metastatic melanoma.
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: target number of patients not reached and disabling team changes
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Melanoma is the most dangerous skin cancer accounting for the highest skin cancer deaths. The prognosis for metastatic melanoma has improved considerably in recent years thanks to advances in the field of immunotherapy. The development of molecules blocking certain immunological "checkpoints" (checkpoints exerted by the CTLA-4 (Cytotoxic T lymphocytes Associated protein 4) and PD-1 (Programmed cell Death protein 1) has made it possible to obtain a significant improvement of the overall survival (OS) of patients treated for metastatic melanoma. Ipilimumab, an antibody blocking CTLA-4, is the first immunotherapy marketed, demonstrating for the first time a therapeutic response, however in a small number of patients (10 to 15%) and with significant toxicity (25% of grade 3-4). Subsequently, a second generation of more effective checkpoint blockers (30 to 40% good response) and less toxic, anti-PD-1 antibodies (pembrolizumab and nivolumab), quickly obtained a marketing authorization in the first line treatment of metastatic melanoma treatment and recently in an adjuvant situation after lymph node dissection in order to limit the risk of recurrence. However, despite these advances, a certain number of patients do not respond to treatment and it remains difficult to predict this therapeutic response. Furthermore, patients treated with ICI often experience cutaneous immune-related adverse events manifesting as skin rash, dermatitis, epidermal necrolysis, and in some cases as vitiligo like depigmentation of the skin, testifying to the development of a specific immunogenicity towards the melanocytes, cells causing melanoma, and responsible for a discoloration of the skin. Several studies have reported that a modification of certain bacteria in the digestive microbiota was predictive of the antitumor response to immunotherapy, while others were predictive of the appearance of significant autoimmune ICI-related toxicities (colitis). Several phase 1 studies have evaluated the impact of taking probiotics or fecal transplants on the tumor response of patients receiving immunotherapy for cancer (NCT 03819296; NCT03817125; NCT03643289). Thus by these new concepts, it would be interesting to assess the composition of the skin microbiota in patients treated with anti-PD-1 immunotherapy for the management of metastatic melanoma and developing during their follow-up vitiligo; predictive side effect of improved survival. These data will be compared to those obtained from patients with common vitiligo. This will be examined in patients skin swabs sampled at lesional and non-lesional sites. Functionally, we will characterize the microbial pathways using shotgun sequencing of microbial genomes and meta-transcriptomics (RNA sequencing of microbial communities of the skin).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Prospective, Monocentric (CHU de Bordeaux, Department of dermatology ), with 4 groups : * vitiligo patients * Metastatic melanoma patients receiving anti-PD-1 but without cutaneous irAEs * Metastatic melanoma patients receiving anti-PD-1 who developed vitiligo lesions * metastatic melanoma patients who developed vitiligo under anti-PD-1, who discontinued the treatment.
| Arm | Type | Receives |
|---|---|---|
| vitiligo patients | Experimental | Procedure: skin swabs at lesional and non-lesional sitesAdult patients diagnosed with Vitiligo according to usual criteria |
| metastatic melanoma patients under anti-PD-1 who did not develop cutaneous irAEs | Experimental | Procedure: skin swabs on skinmetastatic melanoma patients under anti-PD-1 who did not develop Cutaneous Immune-Related Adverse Events (cutaneous irAEs). |
| Metastatic melanoma patients under anti-PD-1 who developed vitiligo lesions | Experimental | Procedure: skin swabs at lesional and non-lesional sitespatients with metastatic melanoma, under anti-PD-1 who developed vitiligo lesions |
| metastatic melanoma patients with vitiligo lesions under anti-PD-1 who discontinued | Experimental | Procedure: skin swabs at lesional and non-lesional sitesMetastatic melanoma who developed vitiligo lesions under anti-PD-1 who discontinued the treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin swabs at lesional and non-lesional sitesIt will be examined in patients skin swabs sampled at lesional and non-lesional sites | Procedure or surgery | Metastatic melanoma patients under anti-PD-1 who developed vitiligo lesions, metastatic melanoma patients with vitiligo lesions under anti-PD-1 who discontinued, vitiligo patients |
| skin swabs on skinIt will be examined in patients skin swabs sampled on skin | Procedure or surgery | metastatic melanoma patients under anti-PD-1 who did not develop cutaneous irAEs |
Primary outcome
Determine skin microbiota by sequencing with vitiligo in advanced melanoma patients under immune-checkpoint inhibitors (ICI) immunotherapy.
Time frame: Day 1
The composition of the skin microbiota will be characterized on skin swabs using shotgun sequencing of microbial genomes and meta-transcriptomics (RNA sequencing of microbial communities of the skin).
Results and safety
The study was stopped early (reason given: target number of patients not reached and disabling team changes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien SENESCHAL, MD, PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin swabs at lesional and non-lesional sites and skin swabs on skin in people with Vitiligo and Skin Melanoma, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: target number of patients not reached and disabling team changes). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine skin microbiota by sequencing with vitiligo in advanced melanoma patients under immune-checkpoint inhibitors (ICI) immunotherapy. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.