Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, Skin Microbiome, Skin Mycobiome, Observational Study, Staphylococcus species
Brief summary
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?
Detailed description
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.
Interventions
None listed
Sponsors
University Hospital Bispebjerg and Frederiksberg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults ≥18 years diagnosed with atopic dermatitis and initiating treatment with lebrikizumab
Exclusion criteria
* Previous treatment with lebrikizumab * Current treatment with other biologics or JAK-inhibitors * Hypersensitivity to lebrikizumab or any of its constituents * Pregnancy or breastfeeding * Active helminth infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in skin microbiome (taxinomic unit) | 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eczema Area and Severity Index (EASI) | 24 weeks | 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). |
| Body Surface Area (BSA) | 24 weeks | 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. |
| Dermatology Life Quality Index (DLQI) | 24 weeks | 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. |
| Patient-Oriented Eczema Measure (POEM) | 24 weeks | 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. |
| Pruritus numeric rating scale (NRS) | 24 weeks | Describing the highest amount of itch experienced during the last 72 hours on an NRS from 0 (no itch) to 10 (worst imaginable itch) |
| Sleep numeric rating scale (NRS) | 24 weeks | 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). |
| Modified Total Lesion Symptom Score (mTLSS) | 24 weeks | 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). |
Countries
Denmark
Contacts
CONTACTIda Marie Nedergaard Thomsen, MD
Outcome results
None listed