common.study.topics.clinical

Hypersensitivity Reactions to House Dust Mite

common.study.values.description

Characterization of the Molecular Mechanisms Involved in Delayed-Type Hypersensitivity Reactions to House Dust Mite, Diphencyprone, Nickel, and Tuberculin Purified Protein Derivative in Healthy Volunteers

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.

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

Pharmaceutical medication involved common.study.methods.has-drugs-yes
Patients and healthy individuals accepted common.study.methods.is-healthy-no

Drug - Prednisone

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.

Drug - Placebo

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

participant.views.study.view.additional

participant.views.study.view.scientific-title

Characterization of the Molecular Mechanisms Involved in Delayed-Type Hypersensitivity Reactions to House Dust Mite, Diphencyprone, Nickel, and Tuberculin Purified Protein Derivative in Healthy Volunteers

common.study.values.clinical-trial-id

NCT03625219

participant.views.study.view.id

dG6ZLb