Effect of Oral Steroids on Skin Outcomes in Atopic Dermatitis — OSAD  

Atopic Dermatitis Clinical Trial

Official title: A Double-blind, Placebo-controlled Study to Evaluate the Effects of Oral Steroids on Skin of Patients With Moderate to Severe Atopic Dermatitis Patients

Status Terminated

Clinical Trial Summary

Atopic Dermatitis (AD), also known as eczema, is a common skin disease characterized by itchy lesions. The prevalence of AD has increased over the past few decades, with 15-30% of children and 2-10% of adults being affected. The lesions of atopic dermatitis patients are very inflamed, with an increased number of inflammatory cells in the skin. The first line treatment for AD is steroids, which reduce inflammation in the skin. There are several ways to measure if the treatment is effective, including clinical and cellular. We are proposing that a controlled skin allergen challenge will be an effective way to measure the effect of steroid at a cellular level through the measurement of inflammatory cells in the late cutaneous response. This will be examined using a placebo-controlled trial.

Clinical Trial Description

This is a double-blind, placebo-controlled, parallel-group clinical trial to evaluate if steroid can block the late cutaneous response after intradermal allergen challenge. Individuals with moderate to severe atopic dermatitis that are develop late cutaneous response to intradermal allergen challenge will be eligible for enrollment. The study is divided into 2 parts.

Part 1: Screening

Subjects who meet all entry criteria will be screened with a medical history and physical examination. If they continue to meet entry criteria, their atopic status will be documented by skin testing against common airborne allergens (including cat, dust mite, grass, pollen) and an intradermal allergen challenge will be performed with a select allergen extract. Only subjects with a documented late cutaneous response to intradermal allergen challenge will be eligible for entry into Part 2 of the study.

Part 2: Dosing and Follow-up

Subjects will be randomly assigned 1:1 to receive either prednisone or placebo treatment. Prednisone treatment will be 5 days of 0.75 mg/kg, 5 days of 0.5 mg/kg and 5 days of 0.25 mg/kg. Before dosing and on Day 9 of dosing an intradermal allergen challenge will be performed and a skin biopsy of the late cutaneous response will be evaluated 24 hours after each intradermal allergen challenge. A sample of blood and skin from a lesion will be obtained before and on Day 9 of treatment. Patients will return for a follow up visit on Day 16 for safety. ;

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

• NCT number: NCT02908698
• Study type: Interventional
• Source: McMaster University
• Status: Terminated
• Phase: N/A
• Start date: January 24, 2017
• Completion date: August 8, 2018