NCT05372003CompletedEarly phase 1
IL-4 and Insulin Resistance for Treatment of Patients With Atopic Dermatitis
IL-4 & Insulin Resistance in Patients With Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 26 Feb 2024
Brief summary (registry, in English)
The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils, their secreted cytokines (interleukin-4), and metabolism in human health and disease states such as obesity and insulin resistance.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 29 Apr 2022
- Start date
- 9 Aug 2022
- Primary completion date
- 23 Feb 2024
- Lead sponsor
- Mayo Clinic
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05372003
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 7
- From 9 Aug 2022 to the primary completion date, 23 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prescription for systemic glucocorticoid, immunosuppressant, antidiabetic medications in the past 6 months.
- Previous participation in a clinical trial with an investigational product in the past 30 days, or 5 half-lives, or twice the duration of the biological effect of the investigational drug (whichever is longest).
- Exposed to more than 4 new chemical entities within 12 months before study enrollment.
Other illness
- Evidence of diabetes mellitus.
- Presence of acute illness.
- Personal history of gastric bypass surgery.
- Any other condition or event considered exclusionary by the PI and the study physician.
Lab values
- Morning Cortisol \< 5 mg/dl (collected before 10.30 am).
- Low hemoglobin or hematocrit.
Other
- Current participation in a weight-loss regimen, with a weight loss \> 10% total body weight in the last 6 months).
- Smoking history in the last 6 months (tobacco, nicotine-containing products including e-cigarettes).
- Pregnant or breastfeeding.
Who the study is looking for
- Ability to sign informed consent form.
- Body mass index (BMI), 22-29 kg/m\^2.
- Diagnosis of Atopic Dermatitis treated with dupilumab for longer than 6 months.
- Diagnosis of Atopic Dermatitis treated with topical steroids or phototherapy.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic - Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.