Role of Interleukin-13 Pathways on Pain and Itch Sensitivity
Recruiting · NCT06503510 · Interventional (participants receive a specific treatment) · Lead sponsor: Aalborg University
View the official record on ClinicalTrials.gov →Interventions studied
CowhageHistaminebovine adrenal medulla (BAM8-22)
What this trial is about
Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms. Research has shown that the proteins interleukins are involved in inflammation and itch in atopic dermatitis. The medicinal product called Lebrikizumab, used for treatment of AD, has shown to block the interleukin called IL-13. The purpose of this experiment is to evaluate the role of IL-13 in itch in both healthy subjects and people with atopic dermatitis.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Healthy men and women
- 18-60 years
Exclusion criteria
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids, or other drugs
- Previous or current history of neurological, dermatological (e.g., AD, psoriasis, etc.), immunological, musculoskeletal, cardiac disorder, or psychiatric diagnoses that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia, etc.)
- Moles, wounds, scars, or tattoos in the area to be treated or tested
- Current use of medications that may affect the trial such as antihistamines and pain killers (use of antihistamines should be discontinued 72 hours before the experiment and all topical agents and emollients should be discontinued 24 hours before the experiment).
- Use of systemic and topical corticosteroids
- Consumption of alcohol or painkillers 24 hours before the study days and between these
- Acute or chronic pain
- Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
- Lack of ability to cooperate
Where it is running
3 locations listed.
- Aalborg University - Gistrup, Aalborg, Denmark
- CNAP - Gistrup, Aalborg, Denmark
- Aalborg University - Aalborg, Denmark, Denmark