Actively Recruiting
The Role of the Interleukin-13 Pathways on Pain and Itch Sensitivity in Patients With Atopic Dermatitis and Healthy Volunteers
Led by Aalborg University · Updated on 2025-06-04
20
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Atopic dermatitis is a chronic inflammatory skin condition affecting about 20% of people worldwide, characterized mainly by intense itch and skin pain. Researchers are studying the role of the protein interleukin-13 (IL-13) in causing itch by using the drug Lebrikizumab, which blocks IL-13, to better understand how this protein influences itch and pain in both healthy people and those with atopic dermatitis. Participants will receive Lebrikizumab through injections under the skin, starting with two doses of 500 mg at baseline and week 2, followed by 250 mg at week 4. The study uses substances like histamine, cowhage, and BAM8-22 to induce itch and pain for assessment. This experimental treatment aims to modify the IL-13 pathway to observe its effects on itch and pain sensitivity. During the study, participants will have itch and pain measured using computerized scales shortly after itch is induced, along with assessments of blood flow and skin reactions. Various pain and sensitivity thresholds will be tested at baseline. Participants will be monitored closely throughout the study period, which runs until the end of 2026, to evaluate these outcomes and ensure safety.
CONDITIONS
Brief Title
Role of Interleukin-13 Pathways on Pain and Itch Sensitivity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy men and women
- Aged between 18 and 60 years
You will not qualify if you...
- Pregnancy or breastfeeding
- Drug addiction including cannabis, opioids, or other drugs
- History of neurological, dermatological, immunological, musculoskeletal, cardiac, or psychiatric disorders affecting results
- Presence of moles, wounds, scars, or tattoos in the treatment area
- Current use of medications like antihistamines, painkillers, or corticosteroids
- Alcohol or painkiller use 24 hours before and during study days
- Acute or chronic pain
- Participation in other trials within one week of entry
- Inability to cooperate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive subcutaneous injections of Lebrikizumab at baseline, week 2, and week 4 to modulate the IL-13 pathway and evaluate its role in pain and itch sensitivity.
3 treatment visits (in-person)
Trial Site Locations
Total: 3 locations
1
Aalborg University
Gistrup, Aalborg, Denmark, 9260
Actively Recruiting
2
CNAP
Gistrup, Aalborg, Denmark, 9260
Active, Not Recruiting
3
Aalborg University
Aalborg, Denmark, Denmark, 9260
Not Yet Recruiting
Research Team
S
Silvia Lo Vecchio
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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