Intertriginous/Periorificial Dermatoses in Patients With IBD on Anti-TNFα: Relative Abundance of Staphylococcus Aureus Within the Lesion Microbiota and Clinical Correlation (micSPIDER).

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Adult or pediatric patient (\>4 years old), diagnosed with IBD and 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)

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

82 Participants
are grouped into 2 trial groups
Group A: SPIDER+ group
Group B: SPIDER- group (control group):

Trial outcomes

Primary outcomes

1

Relative abundance of S. aureus in the SPIDER+ group

Number of read sequences corresponding to S. aureus divided by the total number of read sequences (%) assessed after sequencing swabs from SPIDER lesions

Time frame
Month 0, baseline
2

Relative abundance of S. aureus in the control group

Number of read sequences corresponding to S. aureus divided by the total number of read sequences (%) assessed after sequencing swabs from healthy areas

Time frame
Month 0, baseline
3

Relative abundance of S. aureus in the SPIDER+ group

Number of read sequences corresponding to S. aureus divided by the total number of read sequences (%) assessed after sequencing swabs from SPIDER lesions

Time frame
Month 6
4

Relative abundance of S. aureus according to the Physician's Global Assessment score in the SPIDER+ group

The Physician's Global Assessment score is a clinical scale widely used in dermatology to assess the overall severity of a skin condition. Since there is no specific score for these lesions, it is the only one that can be used. The Physician's Global Assessment score is a global visual assessment of the severity of skin lesions, performed by a healthcare professional (investigator). The Physician's Global Assessment score is an ordinal scale, typically ranging from 0 to 5. A common goal in studies is to achieve a Physician's Global Assessment score of 0 or 1 (resolved or minimal), often with an improvement of at least 2 points from the baseline score. The Physician's Global Assessment is often used as an endpoint in dermatological clinical trials. It is always combined with a quality-of-life score.

Time frame
Month 0, baseline

Secondary outcomes

1

Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Physician's Global Assessment score

The Physician's Global Assessment score is a clinical scale widely used in dermatology to assess the overall severity of a skin condition. Since there is no specific score for these lesions, it is the only one that can be used. The Physician's Global Assessment score is a global visual assessment of the severity of skin lesions, performed by a healthcare professional (investigator). The Physician's Global Assessment score is an ordinal scale, typically ranging from 0 to 5. A common goal in studies is to achieve a Physician's Global Assessment score of 0 or 1 (resolved or minimal), often with an improvement of at least 2 points from the baseline score. The Physician's Global Assessment is often used as an endpoint in dermatological clinical trials. It is always combined with a quality-of-life score.

Time frame
Month 0, baseline
2

Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Physician's Global Assessment score

The Physician's Global Assessment score is a clinical scale widely used in dermatology to assess the overall severity of a skin condition. Since there is no specific score for these lesions, it is the only one that can be used. The Physician's Global Assessment score is a global visual assessment of the severity of skin lesions, performed by a healthcare professional (investigator). The Physician's Global Assessment score is an ordinal scale, typically ranging from 0 to 5. A common goal in studies is to achieve a Physician's Global Assessment score of 0 or 1 (resolved or minimal), often with an improvement of at least 2 points from the baseline score. The Physician's Global Assessment is often used as an endpoint in dermatological clinical trials. It is always combined with a quality-of-life score.

Time frame
Month 12
3

Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Dermatology Quality of Life Index

The Dermatology Quality of Life Index is a standardized, validated, and widely used questionnaire designed to assess the impact of a dermatological condition on a patient's quality of life. It consists of 10 questions, each scored from 0 to 3 points, for a total score ranging from 0 to 30. Topics covered include: symptoms and feelings, discomfort, daily activities, and personal relationships.The optimal goal is a maximum score of 5 points or a reduction of at least 4 points compared to baseline (M0).

Time frame
Month 0, baseline
4

Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Dermatology Quality of Life Index

The Dermatology Quality of Life Index is a standardized, validated, and widely used questionnaire designed to assess the impact of a dermatological condition on a patient's quality of life. It consists of 10 questions, each scored from 0 to 3 points, for a total score ranging from 0 to 30. Topics covered include: symptoms and feelings, discomfort, daily activities, and personal relationships.The optimal goal is a maximum score of 5 points or a reduction of at least 4 points compared to baseline (M0).

Time frame
Month 12

Other outcomes

1

Age of patients

The age of patients will be recorded in years

Time frame
Month 0, baseline
2

Weight of patients

The weight of patients will be recorded in kilograms

Time frame
Month 0, baseline
3

Height of patients

The height of patients will be recorded in centimeters

Time frame
Month 0, baseline
4

Sex of patients

Male/Female/Non-binary

Time frame
Month 0, baseline

Sponsors and contacts

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