Delayed Type HypersensitivityNCT03625219
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
A study testing Prednisone in people with Delayed Type Hypersensitivity, run by Innovaderm Research Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed Type Hypersensitivity
- What is being tested?
- Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jul 2018to 9 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Delayed Type Hypersensitivity
- Being tested
- Prednisone, Placebo
- Medical subject headings
- Hypersensitivity, Delayed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
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.
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Prednisone |
| 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: at least 4 days up to 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start26 Jul 2018
- Primary completion12 Mar 2020
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Type HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cohort A Open label: 4 groups of 10 subjects Cohort B Double-Blind: 1 group of 20 subjects
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625219
- Sponsor's protocol ID
- Inno-6048
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2018
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03625219
- Acronym / sponsor ID
- Inno-6048
- Conditions
- Delayed Type Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cohort A Open label: 4 groups of 10 subjects Cohort B Double-Blind: 1 group of 20 subjects
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Active comparator | Drug: PrednisoneCohort 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 | Drug: PlaceboCohort 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- Subject is in good general health, according to the investigator's judgment based on vital signs, medical history, physical examination, and laboratory tests performed.
Key exclusion criteria (34 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisone40 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 | Prednisone |
| Placebo8 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 | Drug | Placebo |
Primary outcome
Measurement of gene expression levels in skin biopsies following exposure to various antigens.
Time frame: at least 4 days up to 18 days
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.
Time frame: at least 4 days up to 18 days
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.
Time frame: at least 4 days up to 18 days
Measurement of number of inflammatory cells in skin biopsies following exposure to various antigens.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bissonnette principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisone in people with Delayed Type Hypersensitivity, run by Innovaderm Research Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of gene expression levels in skin biopsies following exposure to various antigens. (time frame: at least 4 days up to 18 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.