Atopic DermatitisOSADNCT02908698
Effect of Oral Steroids on Skin Outcomes in Atopic Dermatitis
A study testing Prednisone in people with Atopic Dermatitis, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- 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
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jan 2017to 8 Aug 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female volunteers 18 through 65 years of age.
- Females must not be pregnant
- General good health
- Moderate to severe atopic dermatitis
- Able to understand and give written informed consent and sign a written informed consent form approved by the HIREB (Hamilton Integrated Research Ethics Board)
- Positive skin-prick test to common allergens (including cat, dust mite, grass, pollen)
- Positive late cutaneous response to intradermal allergen challenge
Who cannot join
- Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
- Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
- Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon-γ (IFN-γ), Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- Phototherapy for AD
- Treatment with biologics as follows:
- Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer
Show all 19Show fewer
- Other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer
- Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
- Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. Note: patients may be rescreened after infection resolves
- Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment
- History of human immunodeficiency virus (HIV) infection
- History of hepatitis B or hepatitis C infection
- Presence of skin comorbidities that may interfere with study assessments
- Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study
- Any other medical or psychological condition that may make patient's participation unreliable, or may interfere with study assessments.
- Planned or anticipated major surgical procedure during the patient's participation in this study
- Patient is a member of the investigational team or his/her immediate family
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled Study to Evaluate the Effects of Oral Steroids on Skin of Patients With Moderate to Severe Atopic Dermatitis Patients
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.
Read the detailed description
This is a double-blind, placebo-controlled, parallel-group clinical trial to evaluate if steroid can block the late cutaneous response after intradermal allergen challenge. Individuals with moderate to severe atopic dermatitis that are develop late cutaneous response to intradermal allergen challenge will be eligible for enrollment. The study is divided into 2 parts.
Part 1: Screening
Subjects who meet all entry criteria will be screened with a medical history and physical examination. If they continue to meet entry criteria, their atopic status will be documented by skin testing against common airborne allergens (including cat, dust mite, grass, pollen) and an intradermal allergen challenge will be performed with a select allergen extract. Only subjects with a documented late cutaneous response to intradermal allergen challenge will be eligible for entry into Part 2 of the study.
Part 2: Dosing and Follow-up
Subjects will be randomly assigned 1:1 to receive either prednisone or placebo treatment. Prednisone treatment will be 5 days of 0.75 mg/kg, 5 days of 0.5 mg/kg and 5 days of 0.25 mg/kg. Before dosing and on Day 9 of dosing an intradermal allergen challenge will be performed and a skin biopsy of the late cutaneous response will be evaluated 24 hours after each intradermal allergen challenge. A sample of blood and skin from a lesion will be obtained before and on Day 9 of treatment. Patients will return for a follow up visit on Day 16 for safety.
- Conditions
- Atopic Dermatitis
- Being tested
- Prednisone, Placebo Control
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Total treatment duration: 15 days
Doses are as follows:
5 days daily treatment with 0.75 mg/kg of body weight 5 days daily treatment with 0.5 mg/kg of body weight 5 days daily treatment with 0.25 mg/kg of body weight
Placebo ControlDrug
Total treatment duration: 15 days. Doses will appear identical to prednisone arm.
| Study group | Role | What they receive |
|---|---|---|
| Prednisone Treatment | Experimental | 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 Receives: Drug: Prednisone |
| Placebo Control | Placebo comparator | Placebo will be administered orally for 15 days in a capsule identical to the experimental treatment. Receives: Drug: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Cutaneous Response (LCR)
Measured by size of the wheal.
Measured: Measured 24 hours after intradermal allergen challenge on day 2 and day 9 of study.
Secondary outcomes (2)
Comparison of eosinophils and basophils in the LCR between drug and placebo using histopathology.
The eosinophils and basophils will be measured by histopathology on the LCR biopsy.
Measured: Biopsy of LCR taken 24 hours after intradermal allergen challenge on day 2 and day 9 of study.
Comparison of eosinophils and basophils in the LCR between drug and placebo using flow cytometry.
The eosinophils and basophils will be measured by flow cytometry on the LCR biopsy.
Measured: Biopsy of LCR taken 24 hours after intradermal allergen challenge on day 2 and day 9 of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start24 Jan 2017
- Primary completion8 Aug 2018
- Study completion8 Aug 2018
Why it stopped: Primary outcome was met in the 16 patients that completed the study per protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gail Gauvreau, McMaster University
- Investigators
- Gail Gauvreau, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908698
- Sponsor's protocol ID
- McMaster-OSAD
- Acronym
- OSAD
- Status last verified
- Aug 2018
- First submitted
- 8 Sep 2016
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to tabulate and include IPD in publication in medical journal.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Study to Evaluate the Effects of Oral Steroids on Skin of Patients With Moderate to Severe Atopic Dermatitis Patients
- ClinicalTrials.gov ID
- NCT02908698
- Acronym / sponsor ID
- OSAD / McMaster-OSAD
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary outcome was met in the 16 patients that completed the study per protocol
- Enrolment
- 16 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 21 Sep 2016 (estimated)
- 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.
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.
Detailed description
This is a double-blind, placebo-controlled, parallel-group clinical trial to evaluate if steroid can block the late cutaneous response after intradermal allergen challenge. Individuals with moderate to severe atopic dermatitis that are develop late cutaneous response to intradermal allergen challenge will be eligible for enrollment. The study is divided into 2 parts.
Part 1: Screening
Subjects who meet all entry criteria will be screened with a medical history and physical examination. If they continue to meet entry criteria, their atopic status will be documented by skin testing against common airborne allergens (including cat, dust mite, grass, pollen) and an intradermal allergen challenge will be performed with a select allergen extract. Only subjects with a documented late cutaneous response to intradermal allergen challenge will be eligible for entry into Part 2 of the study.
Part 2: Dosing and Follow-up
Subjects will be randomly assigned 1:1 to receive either prednisone or placebo treatment. Prednisone treatment will be 5 days of 0.75 mg/kg, 5 days of 0.5 mg/kg and 5 days of 0.25 mg/kg. Before dosing and on Day 9 of dosing an intradermal allergen challenge will be performed and a skin biopsy of the late cutaneous response will be evaluated 24 hours after each intradermal allergen challenge. A sample of blood and skin from a lesion will be obtained before and on Day 9 of treatment. Patients will return for a follow up visit on Day 16 for safety.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone Treatment | Experimental | Drug: PrednisonePrednisone 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 |
| Placebo Control | Placebo comparator | Drug: Placebo ControlPlacebo will be administered orally for 15 days in a capsule identical to the experimental treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female volunteers 18 through 65 years of age.
- Females must not be pregnant
- General good health
- Moderate to severe atopic dermatitis
- Able to understand and give written informed consent and sign a written informed consent form approved by the HIREB (Hamilton Integrated Research Ethics Board)
Key exclusion criteria (19 listed)
- Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
- Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
- Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon-γ (IFN-γ), Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- Phototherapy for AD
- Treatment with biologics as follows:
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 |
|---|---|---|
| PrednisoneTotal treatment duration: 15 days Doses are as follows: 5 days daily treatment with 0.75 mg/kg of body weight 5 days daily treatment with 0.5 mg/kg of body weight 5 days daily treatment with 0.25 mg/kg of body weight | Drug | Prednisone Treatment |
| Placebo ControlTotal treatment duration: 15 days. Doses will appear identical to prednisone arm. | Drug | Placebo Control |
Primary outcome
Late Cutaneous Response (LCR)
Time frame: Measured 24 hours after intradermal allergen challenge on day 2 and day 9 of study.
Measured by size of the wheal.
2 secondary outcomes
Comparison of eosinophils and basophils in the LCR between drug and placebo using histopathology.
Time frame: Biopsy of LCR taken 24 hours after intradermal allergen challenge on day 2 and day 9 of study.
Comparison of eosinophils and basophils in the LCR between drug and placebo using flow cytometry.
Time frame: Biopsy of LCR taken 24 hours after intradermal allergen challenge on day 2 and day 9 of study.
Results and safety
The study was stopped early (reason given: Primary outcome was met in the 16 patients that completed the study per protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Individual participant dataSharing planned: Yes. We plan to tabulate and include IPD in publication in medical journal.
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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.
Gail Gauvreau, PhD principal investigator
McMaster University
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 Atopic Dermatitis, run by McMaster University 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 7 inclusion and 19 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: stopped early, as of the sponsor's last update on 20 Aug 2018. 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 was stopped early (reason given: Primary outcome was met in the 16 patients that completed the study per protocol). Results are not available in the source record.
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?
Late Cutaneous Response (LCR) (time frame: Measured 24 hours after intradermal allergen challenge on day 2 and day 9 of study.). 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 20 Aug 2018.