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Skin Adverse Reactions Occuring in Children Treated by Biotherapy for Chronic Inflammatory Disease

Cutaneous Adverse Effects Occurring in Children Under Biological Therapy Given for Chronic Inflammatory Diseases

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04327752
Acronym
MDEBMIC
Enrollment
20
Registered
2020-03-31
Start date
2020-03-12
Completion date
2020-10-01
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Skin Reaction, Biotherapy, Chronic Inflammatory Disease, Dermatologic Complication, Gastrointestinal Disease, Ophthalmology, Pediatric Disorder, Rheumatology

Keywords

Biotherapy, Chronic Inflammatory Disease, skin adverse event, paradoxical reaction, cutaneous manifestation, pediatry, dermatology, gastro-enterology, ophthalmology, rheumatology

Brief summary

Biological treatments (BT) are commonly prescribed to treat chronic inflammatory diseases in children. Paradoxical reactions during treatment with a biological agent can be defined as the appearance or exacerbation of a pathological condition that usually responds to this class of drug while treating a patient for another condition. Limited data are available in children treated by BT on cutaneous paradoxical reactions, or any other cutaneous adverse events occurring during treatment. On the contrary, dermatologists tend to see and manage increasing numbers of cutaneous adverse events, including paradoxical reactions. The aim of this project is to describe the incidence of cutaneous adverse events, including cutaneous paradoxical reactions, occurring in the pediatric population, during a treatment by BT given for a chronic inflammatory disease.

Interventions

OTHERdermatological consultation

Dermatological consultation will be done on every children treated by biotherapy for chronic inflammatory disease in the Amiens hospital.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

* Children under 18 years old * Children treated by biotherapy among : Adalimumab, Golimumab, Infliximab, Ustekinumab, Etanercept, Tocilizumab, Canakinumab, Anakinra, Abatacept. * Children treated for a chronic inflammatory disease (rheumatologic, gastro-enterologic, dermatologic and ophthalmologic) * Children treated in the CHU of Amiens * Parental consent signed

Exclusion criteria

* Age \> 18 ans

Design outcomes

Primary

MeasureTime frameDescription
Variation of the incidence of cutaneous adverse events under biological therapyup to 8 monthsDetermine the variation of the incidence of any skin manifestation under biological therapy, including Paradoxical Reaction (psoriasis, eczema, hidradenitis suppurativa …), non-paradoxical inflammatory reaction, infection, neoplasia, hair and nail manifestation, xerosis.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026