An interventional study of Prednisone and Placebo Control in Atopic Dermatitis, sponsored by McMaster University. Terminated at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-20.
Sponsored by McMaster University · Not applicable, Interventional, and Basic science
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.
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 16 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prednisone will be administered orally for 15 days at the following doses: 0.75 mg/kg of body weight for 5 days 0.5 mg/kg of body weight for 5 days 0.25 mg/kg of body weight for 5 days
Drug: Prednisone
Placebo will be administered orally for 15 days in a capsule identical to the experimental treatment.
Drug: Placebo Control
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
Total treatment duration: 15 days. Doses will appear identical to prednisone arm.
Late Cutaneous Response (LCR)
Measured by size of the wheal.
Time frame: Measured 24 hours after intradermal allergen challenge on day 2 and day 9 of study.
Comparison of eosinophils and basophils in the LCR between drug and placebo using histopathology.
The eosinophils and basophils will be measured by histopathology on the LCR biopsy.
Time frame: Biopsy of LCR taken 24 hours after intradermal allergen challenge on day 2 and day 9 of study.
Comparison of eosinophils and basophils in the LCR between drug and placebo using flow cytometry.
The eosinophils and basophils will be measured by flow cytometry on the LCR biopsy.
Time frame: Biopsy of LCR taken 24 hours after intradermal allergen challenge on day 2 and day 9 of study.
Plan to share: Yes — We plan to tabulate and include IPD in publication in medical journal.
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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