Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT05372003
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05372003
Study Brief:
Protocol Section:
NCT05372003