Atopic DermatitisNeuropNCT01475994
Effect of Pollen Challenges on Dermal Symptoms in Patients With Atopic Dermatitis
A study testing Grass pollen : Dactylis glomerata and Challenge with clean air in people with Atopic Dermatitis, run by Fraunhofer-Institute of Toxicology and Experimental Medicine.
Trial summary
This is a mono-center, randomized, double-blind, placebo-controlled, parallel-group study to assess the effect of challenges with dactylis glomerata pollen in an environmental challenge chamber on dermal symptoms in patients suffering from atopic dermatitis. 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?
- Grass pollen : Dactylis glomerata and Challenge with clean air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Apr 2012
- 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 subjects, aged 18-65 years. Women will be considered for inclusion if they are: Not pregnant, as confirmed by pregnancy test (see flow chart) and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after the last pollen challenge -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- Positive IgE level for Dactylis glomerata of at least CAP FEIA class 3.
- atopic dermatitis (AD) fulfilling the UK criteria of AD
- SCORAD between 20 and 50 points.
- forced Expiratory Volume in the first second (FEV1) ≥ 80% pred. at screening.
- Smokers or non-smokers.
- Body Mass Index ≥18 and ≤ 35.
Who cannot join
- • Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease.
- Asthma other than mild asthma which is treated with short acting beta-2-agonists only and which is controlled according to the current GINA guidelines
- Clinically relevant abnormalities in haematology, blood chemistry, or urinalysis at screening.
- Positive HIV-1/2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV-Ab) test at screening.
- Treatment with medication that might interfere with rescue medication for anaphylactic reactions (e.g. beta blocker).
- Topical steroid treatment (wash out phase: 2 weeks)
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- Topical calcineurin inhibitor treatment (wash out phase 2 weeks)
- UV radiation treatment (wash out phase 4 weeks)
- Systemic immunosuppression treatment (steroids, cyclosporine, azathioprine, Mycophenolat Mofetil (MMF); wash out phase 4 weeks)
- Treatment with antihistamines (wash out phase 1 week)
- Unstable AD during Screening (SCORAD difference of >10 points from Visit 1 to Visit 2)
- Diastolic blood pressure above 95 mmHg.
- Febrile illness within 2 weeks prior to screening.
- Alcohol or drug abuse within 12 month prior to screening.
- Regular daily consumption of more than 1 liter of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form.
- Participation in another clinical trial 30 days prior to enrolment.
- There is a risk of non-compliance with study procedures.
About this study
Official title: Pilot Study to Assess the Effect of Pollen Challenges in an Environmental Challenge Chamber on Dermal Symptoms in Patients With Atopic Dermatitis
This is a mono-center, randomized, double-blind, placebo-controlled, parallel-group study to assess the effect of challenges with dactylis glomerata pollen in an environmental challenge chamber on dermal symptoms in patients suffering from atopic dermatitis.
After each challenge session and on Day 3, Day 4, and Day 5 blood samples will be taken for biomarker assessments. The severity of atopic dermatitis will be rated with the "SCORing Atopic Dermatitis" (SCORAD), with the objective SCORAD and with the assessment of itch and sleeplessness referring to the past 24 hours by a blinded observer (trained dermatologist) on each day including baseline assessments.
- Conditions
- Atopic Dermatitis
- Being tested
- Grass pollen : Dactylis glomerata, Challenge with clean air
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grass pollen : Dactylis glomerataOther
The subjects will be challenged for 4 hours on two consecutive days (Day 1 and Day 2) with either 4000 pollen grains/m3 of dactylis glomerata pollen.
Challenge with clean airOther
The subjects will be challenged for 4 hours on two consecutive days (Day 1 and Day 2) with clean air.
| Study group | Role | What they receive |
|---|---|---|
| Challenge with grass pollen | Experimental | Not described Receives: Other: Grass pollen : Dactylis glomerata |
| Challenge with clean air | Placebo comparator | Not described Receives: Other: Challenge with clean air |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD
Change in SCORAD between Day 1/ baseline (assessed 60 minutes prior to challenge) and Day 3 (assessed post-challenge)
Measured: Day 1/Baseline vs. Day 3
Secondary outcomes (1)
SCORAD Day 4 and 5
Change in SCORAD between Day 1 (assessed 60 minutes prior to challenge) and the Scorad on Day 4 and Day 5 (assessed post challenge).
Measured: Day 1/Baseline vs. Day 4 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionApr 2012
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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School
- Responsible party
- Sponsor
- Investigators
- Jens Hohlfeld, MD, professor, Principal investigator, The Fraunhofer-Gesellschaft
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475994
- Sponsor's protocol ID
- 11-01 Neurop
- Acronym
- Neurop
- Status last verified
- Apr 2012
- First submitted
- 4 Nov 2011
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Effect of Pollen Challenges in an Environmental Challenge Chamber on Dermal Symptoms in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01475994
- Acronym / sponsor ID
- Neurop / 11-01 Neurop
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Collaborators
- Hannover Medical School
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 22 Nov 2011 (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.
This is a mono-center, randomized, double-blind, placebo-controlled, parallel-group study to assess the effect of challenges with dactylis glomerata pollen in an environmental challenge chamber on dermal symptoms in patients suffering from atopic dermatitis.
After each challenge session and on Day 3, Day 4, and Day 5 blood samples will be taken for biomarker assessments. The severity of atopic dermatitis will be rated with the "SCORing Atopic Dermatitis" (SCORAD), with the objective SCORAD and with the assessment of itch and sleeplessness referring to the past 24 hours by a blinded observer (trained dermatologist) on each day including baseline assessments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Challenge with grass pollen | Experimental | Other: Grass pollen : Dactylis glomerata |
| Challenge with clean air | Placebo comparator | Other: Challenge with clean air |
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 subjects, aged 18-65 years. Women will be considered for inclusion if they are: Not pregnant, as confirmed by pregnancy test (see flow chart) and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after the last pollen challenge -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- Positive IgE level for Dactylis glomerata of at least CAP FEIA class 3.
- atopic dermatitis (AD) fulfilling the UK criteria of AD
- SCORAD between 20 and 50 points.
- forced Expiratory Volume in the first second (FEV1) ≥ 80% pred. at screening.
Key exclusion criteria (17 listed)
- • Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease.
- Asthma other than mild asthma which is treated with short acting beta-2-agonists only and which is controlled according to the current GINA guidelines
- Clinically relevant abnormalities in haematology, blood chemistry, or urinalysis at screening.
- Positive HIV-1/2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV-Ab) test at screening.
- Treatment with medication that might interfere with rescue medication for anaphylactic reactions (e.g. beta blocker).
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 |
|---|---|---|
| Grass pollen : Dactylis glomerataThe subjects will be challenged for 4 hours on two consecutive days (Day 1 and Day 2) with either 4000 pollen grains/m3 of dactylis glomerata pollen. | Other | Challenge with grass pollen |
| Challenge with clean airThe subjects will be challenged for 4 hours on two consecutive days (Day 1 and Day 2) with clean air. | Other | Challenge with clean air |
Primary outcome
SCORAD
Time frame: Day 1/Baseline vs. Day 3
Change in SCORAD between Day 1/ baseline (assessed 60 minutes prior to challenge) and Day 3 (assessed post-challenge)
1 secondary outcome
SCORAD Day 4 and 5
Time frame: Day 1/Baseline vs. Day 4 and 5
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 5 Apr 2012.
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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.
Jens Hohlfeld, MD, professor principal investigator
The Fraunhofer-Gesellschaft
Questions about this trial
What is this clinical trial studying?
A study testing Grass pollen : Dactylis glomerata and Challenge with clean air in people with Atopic Dermatitis, run by Fraunhofer-Institute of Toxicology and Experimental Medicine.
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 17 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 5 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
SCORAD (time frame: Day 1/Baseline vs. Day 3). 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 5 Apr 2012.