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This study will be conducted in 2 cohorts.
In Cohort A, approximately 40 subjects will participate in a single-center, open-label, non-randomized, parallel-group trial to investigate the molecular mechanisms involved in delayed-type hypersensitivity (DTH) to various antigens and assess the most appropriate skin challenge antigen to study the effect of systemic treatments on T cells.
Following evaluation of the results in Cohort A, approximately 20 healthy volunteers will be enrolled in Cohort B. This cohort will be a single-center, double-blind, randomized, two-arm, placebo-controlled study to evaluate the effect of corticosteroid treatment on the molecular and cellular phenotype of delayed hypersensitivity response to one if the antigens previously studied in Cohort A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone | Active Comparator | Cohort B only: Subjects will take 40 mg (8 x 5mg tablets) for three consecutive days, then 30 mg (6 x 5mg tablets), 20 mg (4 x 5 mg tablets), 10 mg (2 x 5 mg tablets) and 5 mg (1 x 5 mg tablet) daily for two consecutive days for each dose level for a total of 11 days of treatment. |
|
| Placebo | Placebo Comparator | Cohort B only: 8 tablets for 3 consecutive days; then 6 tablets, 4 tablets, 2 tablets, and 1 tablet daily for 2 consecutive days for each tablet count for a total of 11 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | 40 mg (8 x 5mg tablets) for three consecutive days, then 30 mg (6 x 5mg tablets), 20 mg (4 x 5 mg tablets), 10 mg (2 x 5 mg tablets) and 5 mg (1 x 5 mg tablet) daily for two consecutive days for each dose level for a total of 11 days of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of gene expression levels in skin biopsies following exposure to various antigens. | Measurement of gene expression levels in skin biopsies following exposure to various antigens. | at least 4 days up to 18 days |
| Measurement of epidermal thickness in skin biopsies following exposure to various antigens. | Measurement of epidermal thickness in skin biopsies following exposure to various antigens. | at least 4 days up to 18 days |
| Measurement of number of inflammatory cells in skin biopsies following exposure to various antigens. | Measurement of number of inflammatory cells in skin biopsies following exposure to various antigens. | at least 4 days up to 18 days |
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Inclusion Criteria:
Cohort A:
Cohort B:
Note: Hormonal contraceptives must have been on a stable dose for at least 4 weeks before screening.
Note: The above list of contraceptive methods does not apply to subjects who are abstinent for at least 4 weeks before Day 1 and will continue to be abstinent from penile-vaginal intercourse throughout the study. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.
Note: Women of nonchildbearing potential are defined as follows:
Female who has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or;
Female who has had a cessation of menses for at least 12 months prior to screening without an alternative medical cause, and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (refer to laboratory reference ranges for confirmatory levels).
Exclusion Criteria:
Cohort A:
Cohort B:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bissonnette | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovaderm Research Inc. | Montreal | Quebec | H2K 4L5 | Canada |
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Cohort A Open label: 4 groups of 10 subjects Cohort B Double-Blind: 1 group of 20 subjects
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| Placebo | Drug | 8 tablets for 3 consecutive days; then 6 tablets, 4 tablets, 2 tablets, and 1 tablet daily for 2 consecutive days for each tablet count for a total of 11 days |
|
| ID | Term |
|---|---|
| D006968 | Hypersensitivity, Delayed |
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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