Effect of Oral Steroids on Skin Outcomes in Atopic Dermatitis

NCT02908698 | Terminated

• 1 other identifier: McMaster-OSAD
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Late Cutaneous Response (LCR)

  Measured by size of the wheal.

  Measured 24 hours after intradermal allergen challenge on day 2 and day 9 of study.

Secondary Outcomes (2)

• Comparison of eosinophils and basophils in the LCR between drug and placebo using histopathology.

  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.

  Biopsy of LCR taken 24 hours after intradermal allergen challenge on day 2 and day 9 of study.

Study Arms (2)

Prednisone Treatment

EXPERIMENTAL

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 Control

PLACEBO COMPARATOR

Placebo will be administered orally for 15 days in a capsule identical to the experimental treatment.

Drug: Placebo Control

Interventions

Prednisone DRUG

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

Prednisone Treatment

Placebo Control DRUG

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

Placebo Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female volunteers 18 through 65 years of age.
• Females must not be pregnant
• General good health
• Moderate to severe atopic dermatitis
• Able to understand and give written informed consent and sign a written informed consent form approved by the HIREB (Hamilton Integrated Research Ethics Board)
• Positive skin-prick test to common allergens (including cat, dust mite, grass, pollen)
• Positive late cutaneous response to intradermal allergen challenge

You may not qualify if:

• Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
• Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
• Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon-γ (IFN-γ), Janus kinase inhibitors, azathioprine, methotrexate, etc.)
• Phototherapy for AD
• Treatment with biologics as follows:
• Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer
• Other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer
• Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
• Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit
• Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. Note: patients may be rescreened after infection resolves
• Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis \[TB\], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment
• History of human immunodeficiency virus (HIV) infection
• History of hepatitis B or hepatitis C infection
• Presence of skin comorbidities that may interfere with study assessments
• Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Gail Gauvreau, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Gail Gauvreau

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 21, 2016
• Study Start: January 24, 2017
• Primary Completion: August 8, 2018
• Study Completion: August 8, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)