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Changes in Skin Myco- and Microbiome After Lebrikizumab Treatment

ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Bispebjerg and Frederiksberg

About this trial

The goal of this observational study is to characterize the skin myco- and microbiome of patients with atopic dermatitis before and after initiation of treatment with lebrikizumab. The main questions it aims to answer are:

Does the skin mycobiome change with treatment? Does the skin microbiome change with treatment? Does the abundance of Staphylococcus species change with treatment?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥18 years diagnosed with atopic dermatitis and initiating treatment with lebrikizumab

Disqualifiers

Previous treatment with lebrikizumab

Current treatment with other biologics or JAK-inhibitors

Hypersensitivity to lebrikizumab or any of its constituents

Pregnancy or breastfeeding

Trial population

Patients with atopic dermatitis recruited from the Departments of Dermatology at Aarhus University Hospital, Odense University Hospital, or Bispebjerg University Hospital.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Changes in skin microbiome (taxinomic unit)

Collection of skin swabs at baseline, week 4 and week 16. Analyzing of skin swabs using 16S rRNA gene sequencing, TUF gene sequencing, 18S rRNA gene sequencing and mpsA gene sequencing.

Time frame
16 weeks

Secondary outcomes

1

Eczema Area and Severity Index (EASI)

The EASI is a well-established tool for measuring eczema severity, assessing both the extent of affected areas and the intensity of inflammation. Scores range from 0 to 72, with categories defined as follows: almost clear (0.1-1), mild (1.1-7), moderate (7.1-21), severe (21.1-50), and very severe (50.1-72).

Time frame
24 weeks
2

Body Surface Area (BSA)

BSA estimates the percentage of the body affected by eczema, with 100% representing total body surface area involvement. This measure is particularly useful in conditions that affect extensive skin regions, providing a clear view of disease spread.

Time frame
24 weeks
3

Dermatology Life Quality Index (DLQI)

The DLQI is a validated questionnaire that assesses the impact of skin diseases on quality of life. Scores range from 0 to 30, where higher scores indicate a more significant impact on the patient's life. This tool is widely used in dermatology to capture the subjective burden of skin conditions.

Time frame
24 weeks
4

Patient-Oriented Eczema Measure (POEM)

The POEM is a patient-reported outcome measure designed to assess eczema symptoms and their impact from the patient's perspective. It includes questions on itch, sleep disturbance, and other symptoms, with scores ranging from 0 to 28, reflecting symptom severity and frequency.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Bispebjerg and Frederiksberg

Lead sponsor

Source ClinicalTrials.gov
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