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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

Primary Purpose

Delayed Type Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prednisone
Placebo
Sponsored by
Innovaderm Research Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Delayed Type Hypersensitivity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Cohort A:

  • Subject is in good general health, according to the investigator's judgment based on vital signs, medical history, physical examination, and laboratory tests performed. For woman of childbearing potential, has had a negative urine pregnancy test at screening and on Day 1 (baseline).
  • Subjects has acceptable reaction to selected antigens.
  • Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
  • Subjects must be willing to comply with all study procedures and must be available for the duration of the study.

Cohort B:

  • Subject is in good general health, according to the investigator's judgment based on vital signs, medical history, physical examination, and laboratory tests performed.
  • For subject (woman) involved in any sexual intercourse that could lead to pregnancy, subject agrees that an effective contraceptive method will be used, from at least 4 weeks prior to screening until at least 4 weeks after the last study product administration. Effective contraceptive methods include hormonal contraceptives (combined oral contraceptive, patch, vaginal ring, injectable, or implant), intrauterine devices or intrauterine systems, vasectomized partner(s), tubal ligation, or a barrier method of contraception (male condom, female condom, cervical cap, diaphragm, contraceptive sponge) in conjunction with spermicide.

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).

    • For woman of childbearing potential, has had a negative urine and serum pregnancy test at screening and negative urine pregnancy test at Day 1 (baseline).
    • Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
    • Subjects must be willing to comply with all study procedures and must be available for the duration of the study.

Exclusion Criteria:

Cohort A:

  • Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
  • Subject has a known history of severe allergic reaction (local or systemic) to the tested hapten.
  • Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments including active urticaria, psoriasis, atopic dermatitis, active contact dermatitis and excited (angry back) skin syndrome.
  • Medical history of dermatographism.
  • History of contact dermatitis to medical adhesive bandages or glue.
  • Presence of any scar tissue, tattoos, scratches, open sores, excessive hair, or skin damages at tested/injection sites that in the opinion of the investigator may interfere with study evaluations.
  • Subject is known to have immune deficiency or is immunocompromised.
  • Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or infection with human immunodeficiency virus).
  • Subject has evidence or suspicion of active or latent TB or a clear history of treatment for TB disease or infection
  • Subject has a hypersensitivity to any of the components of the patch test matrix or the hapten excipients.
  • Subject has a known hypersensitivity to Tuberculin Purified Protein Derivative or to any components of the formulation or container. .
  • Subject previously had a severe reaction (e.g., necrosis, blistering, anaphylactic shock or ulcerations) to a previous tuberculin skin test

Cohort B:

  • Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
  • Subject has a known history of severe allergic reaction (local or systemic) to the tested hapten.
  • Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments including active urticaria, psoriasis, atopic dermatitis, active contact dermatitis and excited (angry back) skin syndrome.
  • Medical history of dermatographism.
  • History of contact dermatitis to medical adhesive bandages or glue.
  • Presence of any scar tissue, tattoos, scratches, open sores, excessive hair, or skin damages at tested/injection sites that in the opinion of the investigator may interfere with study evaluations.
  • Subject is known to have immune deficiency or is immunocompromised.
  • Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or infection with human immunodeficiency virus).
  • Subject has a contra-indication, or who would be at increased risk of adverse effects to systemic corticosteroid (e.g. active systemic fungal infection, extensive viral disease (such as measles, chickenpox and herpes simplex on the eye), diabetes, heart problems, peptic ulcer, inflammatory bowel disease, diverticulitis, active depression or psychosis, osteoporosis, cataracts, glaucoma, bleeding or clotting problems, high blood pressure, neurological problems, hypothyroidism, myasthenia, kidney diseases, liver diseases, history of low potassium or calcium in blood) that in the opinion of the investigator may put the subject at risk during the trial.
  • Subject had a treated or non-treated systemic infection (bacterial or viral) within 4 weeks prior to screening until Day 1 (baseline).
  • Subject has evidence or suspicion of active or latent TB or a clear history of treatment for TB disease or infection
  • Subject received a live or live/attenuated vaccination within 4 weeks prior screening or intends to receive a live or live/attenuated vaccination during the course of the study.
  • Subject has a positive result to the QuantiFERON-TB Gold test or Tuberculin Purified Protein Derivative (Mantoux) test (if applicable) at the screening visit.
  • Subject has any clinically significant medical condition or physical/laboratory/ vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
  • Use of any other concurrent medications known or suspected to interfere with study evaluations or that may pose a safety risk.
  • Subject has a hypersensitivity to any of the components of the patch test matrix or the hapten excipients.
  • Subject has a known hypersensitivity to Tuberculin Purified Protein Derivative or to any components of the formulation or container.
  • Subject previously had a severe reaction (e.g., necrosis, blistering, anaphylactic shock or ulcerations) to a previous tuberculin skin test
  • Subject has a known or suspected allergy or intolerance to excipients of the placebo.
  • Subject has a known or suspected allergy to prednisone or any of its excipients or any other corticosteroids.

Sites / Locations

  • Innovaderm Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Prednisone

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
Measurement of epidermal thickness in skin biopsies following exposure to various antigens.
Measurement of epidermal thickness in skin biopsies following exposure to various antigens.
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.

Secondary Outcome Measures

Full Information

First Posted
July 17, 2018
Last Updated
July 16, 2020
Sponsor
Innovaderm Research Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03625219
Brief 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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
June 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovaderm Research Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Type Hypersensitivity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cohort A Open label: 4 groups of 10 subjects Cohort B Double-Blind: 1 group of 20 subjects
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Measurement of gene expression levels in skin biopsies following exposure to various antigens.
Description
Measurement of gene expression levels in skin biopsies following exposure to various antigens.
Time Frame
at least 4 days up to 18 days
Title
Measurement of epidermal thickness in skin biopsies following exposure to various antigens.
Description
Measurement of epidermal thickness in skin biopsies following exposure to various antigens.
Time Frame
at least 4 days up to 18 days
Title
Measurement of number of inflammatory cells in skin biopsies following exposure to various antigens.
Description
Measurement of number of inflammatory cells in skin biopsies following exposure to various antigens.
Time Frame
at least 4 days up to 18 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cohort A: Subject is in good general health, according to the investigator's judgment based on vital signs, medical history, physical examination, and laboratory tests performed. For woman of childbearing potential, has had a negative urine pregnancy test at screening and on Day 1 (baseline). Subjects has acceptable reaction to selected antigens. Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures. Subjects must be willing to comply with all study procedures and must be available for the duration of the study. Cohort B: Subject is in good general health, according to the investigator's judgment based on vital signs, medical history, physical examination, and laboratory tests performed. For subject (woman) involved in any sexual intercourse that could lead to pregnancy, subject agrees that an effective contraceptive method will be used, from at least 4 weeks prior to screening until at least 4 weeks after the last study product administration. Effective contraceptive methods include hormonal contraceptives (combined oral contraceptive, patch, vaginal ring, injectable, or implant), intrauterine devices or intrauterine systems, vasectomized partner(s), tubal ligation, or a barrier method of contraception (male condom, female condom, cervical cap, diaphragm, contraceptive sponge) in conjunction with spermicide. 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). For woman of childbearing potential, has had a negative urine and serum pregnancy test at screening and negative urine pregnancy test at Day 1 (baseline). Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures. Subjects must be willing to comply with all study procedures and must be available for the duration of the study. Exclusion Criteria: Cohort A: Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study. Subject has a known history of severe allergic reaction (local or systemic) to the tested hapten. Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments including active urticaria, psoriasis, atopic dermatitis, active contact dermatitis and excited (angry back) skin syndrome. Medical history of dermatographism. History of contact dermatitis to medical adhesive bandages or glue. Presence of any scar tissue, tattoos, scratches, open sores, excessive hair, or skin damages at tested/injection sites that in the opinion of the investigator may interfere with study evaluations. Subject is known to have immune deficiency or is immunocompromised. Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or infection with human immunodeficiency virus). Subject has evidence or suspicion of active or latent TB or a clear history of treatment for TB disease or infection Subject has a hypersensitivity to any of the components of the patch test matrix or the hapten excipients. Subject has a known hypersensitivity to Tuberculin Purified Protein Derivative or to any components of the formulation or container. . Subject previously had a severe reaction (e.g., necrosis, blistering, anaphylactic shock or ulcerations) to a previous tuberculin skin test Cohort B: Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study. Subject has a known history of severe allergic reaction (local or systemic) to the tested hapten. Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments including active urticaria, psoriasis, atopic dermatitis, active contact dermatitis and excited (angry back) skin syndrome. Medical history of dermatographism. History of contact dermatitis to medical adhesive bandages or glue. Presence of any scar tissue, tattoos, scratches, open sores, excessive hair, or skin damages at tested/injection sites that in the opinion of the investigator may interfere with study evaluations. Subject is known to have immune deficiency or is immunocompromised. Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or infection with human immunodeficiency virus). Subject has a contra-indication, or who would be at increased risk of adverse effects to systemic corticosteroid (e.g. active systemic fungal infection, extensive viral disease (such as measles, chickenpox and herpes simplex on the eye), diabetes, heart problems, peptic ulcer, inflammatory bowel disease, diverticulitis, active depression or psychosis, osteoporosis, cataracts, glaucoma, bleeding or clotting problems, high blood pressure, neurological problems, hypothyroidism, myasthenia, kidney diseases, liver diseases, history of low potassium or calcium in blood) that in the opinion of the investigator may put the subject at risk during the trial. Subject had a treated or non-treated systemic infection (bacterial or viral) within 4 weeks prior to screening until Day 1 (baseline). Subject has evidence or suspicion of active or latent TB or a clear history of treatment for TB disease or infection Subject received a live or live/attenuated vaccination within 4 weeks prior screening or intends to receive a live or live/attenuated vaccination during the course of the study. Subject has a positive result to the QuantiFERON-TB Gold test or Tuberculin Purified Protein Derivative (Mantoux) test (if applicable) at the screening visit. Subject has any clinically significant medical condition or physical/laboratory/ vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results. Use of any other concurrent medications known or suspected to interfere with study evaluations or that may pose a safety risk. Subject has a hypersensitivity to any of the components of the patch test matrix or the hapten excipients. Subject has a known hypersensitivity to Tuberculin Purified Protein Derivative or to any components of the formulation or container. Subject previously had a severe reaction (e.g., necrosis, blistering, anaphylactic shock or ulcerations) to a previous tuberculin skin test Subject has a known or suspected allergy or intolerance to excipients of the placebo. Subject has a known or suspected allergy to prednisone or any of its excipients or any other corticosteroids.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bissonnette
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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