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Corticosteroid

Prednisone Treatment for Atopic Dermatitis (OSAD Trial)

N/A
Waitlist Available
Led By Gail Gauvreau, PhD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up biopsy of lcr taken 24 hours after intradermal allergen challenge on day 2 and day 9 of study.
Awards & highlights
All Individual Drugs Already Approved
Approved for 30 Other Conditions

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.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured 24 hours after intradermal allergen challenge on day 2 and day 9 of study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured 24 hours after intradermal allergen challenge on day 2 and day 9 of study. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Late Cutaneous Response (LCR)
Secondary study objectives
Basophils
Comparison of eosinophils and basophils in the LCR between drug and placebo using histopathology.

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Dysphagia-esophageal radiation
8%
Hypoglycemia
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Prednisone TreatmentExperimental Treatment1 Intervention
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
Group II: Placebo ControlPlacebo Group1 Intervention
Placebo will be administered orally for 15 days in a capsule identical to the experimental treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
FDA approved

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
914 Previous Clinical Trials
2,615,035 Total Patients Enrolled
Gail Gauvreau, PhDPrincipal InvestigatorMcMaster University
15 Previous Clinical Trials
566 Total Patients Enrolled
~2 spots leftby Oct 2025
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