IL-4 and Insulin Resistance for Treatment of Patients With Atopic Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-09

Study Completion Date

2024-02-23

Brief Summary

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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.

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Detailed Description

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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 of insulin sensitivity in subjects on dupilumab vs subjects matched for similar weight and BMI, with atopic dermatitis, but without dupilumab therapy (phototherapy).

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects on Dupilumab

individuals with atopic dermatitis placed on dupilumab for more than 6 months will be eligible to this study. Their metabolic profile will be compared to the group of "Subjects on Phototherapy"

Group Type EXPERIMENTAL

Dupilumab

Intervention Type DRUG

dupilumab injections will be prescribed and managed by dermatology as standard of care

Subjects on Phototherapy

individuals with atopic dermatitis placed on phototherapy for more than 6 months will be eligible to this study to serve as an active comparator to the "Subjects with Dupilumab"

Group Type ACTIVE_COMPARATOR

Photo therapy

Intervention Type OTHER

light therapy will be prescribed and managed by dermatology as standard of care

Interventions

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Dupilumab

dupilumab injections will be prescribed and managed by dermatology as standard of care

Intervention Type DRUG

Photo therapy

light therapy will be prescribed and managed by dermatology as standard of care

Intervention Type OTHER

Other Intervention Names

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light therapy

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes