An observational study in Atopic Dermatitis, sponsored by University Hospital Bispebjerg and Frederiksberg. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by University Hospital Bispebjerg and Frederiksberg · Observational
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?
Research hypothesis: Lebrikizumab changes the skin micro- and mycobiome.
Primary objective:
To observe changes in the skin micro- and mycobiome during treatment with lebrikizumab, a newly available biologic used in adult patients with moderate-to-severe atopic dermatitis (AD). Lebrikizumab is a high-affinity monoclonal antibody that selectively targets interleukin-13; its effect on the skin microbiome and mycobiome has not previously been investigated.
Primary endpoint: Quantification and characterization of bacterial and fungal population diversity on the skin.
Secondary objectives:
To investigate the correlation between changes in the skin micro- and mycobiome and objective and subjective clinical improvement in AD, as measured by validated disease evaluation tools and patient-reported outcomes. Objective improvement will be measured using the Eczema Area and Severity Index (EASI), modified Total Lesion Symptom Score (mTLSS), and affected Body Surface Area (BSA). Subjective patient-reported outcomes will be measured using the Dermatology Life Quality Index (DLQI), Pruritus Numeric Rating Scale (Pruritus NRS), Sleep NRS, and Patient-Oriented Eczema Measure (POEM).
Findings on the microbiome and mycobiome from this study will be compared with findings from previous microbiome and mycobiome research on other AD treatments, including topical therapies and biologics.
Secondary endpoint: Quantification and characterization of bacterial and fungal population diversity on the skin in correlation with AD symptoms.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 60 is below the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →University Hospital Bispebjerg and Frederiksberg is the lead sponsor of 69 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with atopic dermatitis recruited from the Departments of Dermatology at Aarhus University Hospital, Odense University Hospital, or Bispebjerg University Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
Pruritus numeric rating scale (NRS)
Describing the highest amount of itch experienced during the last 72 hours on an NRS from 0 (no itch) to 10 (worst imaginable itch)
Time frame: 24 weeks
Sleep numeric rating scale (NRS)
Describing to what extent itching interfered with the patient's sleep last 3 night on an NRS scale from 0 (no interference) to 10 (maximal interference).
Time frame: 24 weeks
Modified Total Lesion Symptom Score (mTLSS)
The mTLSS is a score designed to assess the severity degree of chronic hand eczema (CHE) which may be present in a substantial part of patients with atopic dermatitis. The score ranges from 0 (no changes) to 21 points (severe hand eczema).
Time frame: 24 weeks
Started Jun 2025 (actual). Primary completion is estimated for Dec 2026, 18 months after the start.
Of 96 non-industry observational studies under Dermatitis, Atopic, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 19. This study's planned 18 months is below that.
Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 17.
How these figures are worked out, and which studies are left out of them.
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University Hospital Bispebjerg and Frederiksberg