Changes in Skin Myco- and Microbiome After Lebrikizumab Treatment

NCT07807228 | Recruiting

• 1 other identifier: H-24080179
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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?

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Skin Microbiome; Skin Mycobiome; Observational Study; Staphylococcus species

Outcome Measures

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.

  16 weeks

Secondary Outcomes (7)

• Eczema Area and Severity Index (EASI)

  24 weeks

• Body Surface Area (BSA)

  24 weeks

• Dermatology Life Quality Index (DLQI)

  24 weeks

• Patient-Oriented Eczema Measure (POEM)

  24 weeks

• Pruritus numeric rating scale (NRS)

  24 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Dermatology Department Bispebjerg

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Ida Marie Nedergaard Thomsen, MD

CONTACT

+45 38 63 61 73; ida.marie.nedergaard.thomsen.01@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: September 8, 2026
• Study Start: June 5, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-06

Locations

DK (1)