Status:
COMPLETED
IL-4 and Insulin Resistance for Treatment of Patients With Atopic Dermatitis
Lead Sponsor:
Mayo Clinic
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
Brief Summary
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...
Detailed Description
Patients with a body mass index (BMI) less than 30 kg/m2 and a history of atopic dermatitis on long-term (greater than 6 months) treatment with dupilumab. Researchers will compare in vivo evaluations ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Any prescription for systemic glucocorticoid, immunosuppressant, antidiabetic medications in the past 6 months.
- Evidence of diabetes mellitus.
- Morning Cortisol \< 5 mg/dl (collected before 10.30 am).
- Presence of acute illness.
- Low hemoglobin or hematocrit.
- 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.
- Personal history of gastric bypass surgery.
- 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.
- Any other condition or event considered exclusionary by the PI and the study physician.
Key Trial Info
Start Date :
August 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05372003
Start Date
August 9 2022
End Date
February 23 2024
Last Update
February 26 2024
Active Locations (1)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259