Intertriginous/Periorificial Dermatoses in Patients With IBD on Anti-TNFα: Relative Abundance of Staphylococcus Aureus Within the Lesion Microbiota and Clinical Correlation (micSPIDER).
Observational · No treatment assigned · 5 sites · Centre Hospitalier Universitaire de Nīmes
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases, Crohn's Disease and Skin Diseases. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 4 and older
- Any sex
Some of the main requirements, copied from the record:
- Diagnosed with IBD
- Receiving anti-TNFα therapy
- WITH skin lesions such as crusted rhinitis ± inflammatory alopecic scalp lesions ± intertrigo of the large skin folds ± folliculitis (Scalp and Periorificial Inflammatory DERmatis, SPIDER)
Plus 3 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 82 participants are expected to take part.
- Start date: 2026-09 (planned).
- Main results expected around 2028-09 (estimate from the record).
- 5 study sites listed in France.
Main thing being measured
- Relative abundance of S. aureus in the SPIDER+ group (Month 0, baseline)
In the researchers’ words
The main objective of this study is to evaluate the change in the relative abundance of S. aureus within the lesion-site skin microbiota in SPIDER patients (change between inclusion and 6 months), and to assess whether this change in S. aureus abundance is associated with a favorable (or unfavorable) evolution of the wounds over the same period.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases; Crohn's Disease; Skin Diseases; Dermatitis |
| Lead sponsor | Centre Hospitalier Universitaire de Nīmes |
| Enrollment | 82 (estimated) |
| Start date | 2026-09 |
| Primary completion (est.) | 2028-09 |
| First posted | 2026-09-10 |
| Last updated | 2026-09-10 |
| Official title | Inflammatory Skin Diseases of Skin Folds and Perioral Areas (SPIDER) in Patients With Chronic Inflammatory Bowel Disease on Anti-TNFα Therapy: Characterization of the Staphylococcus Aureus Population Within the Lesion Microbiota and Correlation With Clinical Findings |
| ClinicalTrials.gov ID | NCT07812675 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: * Diagnosed with IBD * Receiving anti-TNFα therapy * WITH skin lesions such as crusted rhinitis ± inflammatory alopecic scalp lesions ± intertrigo of the large skin folds ± folliculitis (Scalp and Periorificial Inflammatory DERmatis, SPIDER) * Parental consent for minor patients * Patient who has provided free and informed consent and has signed the consent form * Patient affiliated to or beneficiary of a health insurance system Exclusion Criteria: * Patients for whom a change in therapy is planned within 6 months (SPIDER+). * Patients receiving antibiotics (systemic or topical) at the time of enrollment, with a window of at least 1 month. * Patients who have participated in a clinical drug trial within the last three months * Patients currently in an exclusion period determined by a previous study * Patients under legal guardianship, conservatorship, or trusteeship * Patients who refuse to sign the informed consent form * Pregnant or breastfeeding patients.
Locations (5)
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier de MILLAU | Millau, Aveyron | France | |
| Nîmes University Hospital | Nîmes, Gard | France | |
| CHU de Béziers | Béziers, Hérault | France | |
| CHU de Montpellier, Hôpital Arnaud de Villeneuve | Montpellier, Hérault | France | |
| Montpellier University Hospital, Saint Eloi | Montpellier, Hérault | France |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.