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Effect of Oral Steroids on Skin Outcomes in Atopic Dermatitis

NCT02908698 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-08-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Prednisone

Total treatment duration: 15 days Doses are as follows: 5 days daily treatment with 0.75 mg/kg of body weight 5 days daily treatment with 0.5 mg/kg of body weight 5 days daily treatment with 0.25 mg/kg of body weight

DRUG

Placebo Control

Total treatment duration: 15 days. Doses will appear identical to prednisone arm.

Sponsors & Collaborators

Principal Investigators

  • Gail Gauvreau, PhD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-24
Primary Completion
2018-08-08
Completion
2018-08-08

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02908698 on ClinicalTrials.gov