Atopic DermatitisNCT07918586
Localized Aeroallergen Exposure in Atopic Dermatitis
A study testing Localized grass pollen allergen exposure in people with Atopic Dermatitis, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 2 sites in Germany.
Trial summary
This pilot study evaluates skin reactions following localized aeroallergen exposure in adults with 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?
- Localized grass pollen allergen exposure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Able and willing to give written informed consent.
- 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 meets 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 start of the study until at least 72 hours after the last study visit -, 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 grass pollen (Phadia g6, Lieschgras) of at least CAP FEIA class 3 (≥3,50 kU/l) at screening or in previous year.
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- Atopic dermatitis fulfilling the UK criteria of AD.
- Local SCORAD for erythema domain 1 or 2 in exposed area (cubital fossa / lower arm).
- Local IGA 1 or 2.
- Difference of Local SCORAD between both arms ≤ 2.
- BMI ≥18 and ≤ 40.
Who cannot join
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
- 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.
- Positive HIV-1/2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCVAb) test at screening or test not performed.
- Treatment with medication that might interfere with rescue medication for the management of allergic reactions (e.g. beta blocker).
- Topical (skin) steroid treatment (wash out phase: 2 weeks before day 1).
- Topical calcineurin inhibitor treatment (wash out phase 2 weeks before day 1).
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- UV radiation treatment (wash out phase 4 weeks before day 1).
- Systemic immunosuppression treatment (steroids, biologics, e.g. dupilumab, JAK-Inhibitors, cyclosporine, azathioprine, Mycophenolat Mofetil (MMF); wash out phase 3 months, before day 1.
- Treatment with high dose inhaled corticosteroids.
- Treatment with antihistamines (wash out phase 1 week before day 1).
- Unstable AD during Screening (SCORAD difference of >15 points from Visit 1 to Visit 2).
- Diastolic blood pressure above 95 mmHg.
- Acute respiratory infection 2 weeks prior to screening visit.
- Alcohol or drug abuse within 12 months 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 enrollment.
- There is a risk of non-compliance with study procedures.
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
- History of an acute infection four weeks prior to the informed consent visit.
- Subject has received previous immunotherapy treatment with any grass pollen allergen within 2 years prior to screening.
- Subject is receiving ongoing treatment with any specific immunotherapy for other allergies.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites
Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Clinical Airway Research
Hanover, Lower Saxony, 30625
Jens Hohlfeld, Prof. Dr. med., +49 511 5350-8101, jens.hohlfeld@item.fraunhofer.de
Hannover Medical School, Department of Dermatology and Allergy
Hanover, Lower Saxony, 30625
Stephan Traidl, PD Dr. med., +49 511 532-5053, Traidl.Stephan@mh-hannover.de
About this study
Official title: Pilot Study to Assess the Localized Aeroallergen Exposure Induced Skin Reaction in Patients With Atopic Dermatitis
This pilot study evaluates skin reactions following localized aeroallergen exposure in adults with atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- Localized grass pollen allergen exposure, Localized placebo exposure
- Keywords
- Aeroallergen exposure, Grass pollen
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Localized grass pollen allergen exposureOther
Localized grass pollen allergen exposure on two consecutive days.
Localized placebo exposureOther
Localized placebo exposure on two consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Allocation A | Experimental | Localized grass pollen allergen exposure on the left forearm and localized placebo exposure on the right forearm. Receives: Other: Localized grass pollen allergen exposure; Other: Localized placebo exposure |
| Allocation B | Experimental | Localized placebo exposure on the left forearm and localized grass pollen allergen exposure on the right forearm. Receives: Other: Localized grass pollen allergen exposure; Other: Localized placebo exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the change of local SCORAD
The primary endpoint is defined as the difference in the change of local SCORAD between the grass pollen-exposed arm and the placebo-exposed arm from baseline to post-provocation assessment. For each subject, the change in local SCORAD will be calculated separately for each arm as follows: ΔSCORAD_grass = local SCORAD_grass (Day 3) - local SCORAD_grass (Baseline); ΔSCORAD_placebo = local SCORAD_placebo (Day 3) - local SCORAD_placebo (Baseline). The primary endpoint is then calculated as: Primary endpoint = ΔSCORAD_grass - ΔSCORAD_placebo.
Measured: Baseline to Day 3
Secondary outcomes (7)
Change in total SCORAD
Assess the change in total SCORAD between pre-provocation baseline and one day after the second exposure (day 3).
Measured: Baseline to Day 3
Change in EASI
Assess the change in EASI between pre-provocation baseline and one day after the second exposure (day 3). EASI assesses the extent and severity of atopic dermatitis based on erythema, infiltration/papulation, excoriation, and lichenification. Total scores range from 0 to 72, with higher scores indicating greater disease severity.
Measured: Baseline to Day 3
Change in local IGA
Evaluate disease severity by the change in local IGA between baseline and one day after the second exposure (day 3).
Measured: Baseline to Day 3
Change in itch intensity
Evaluate itch intensity related to provocation by the change in itch VAS between baseline and one day after the second exposure (day 3).
Measured: Baseline to Day 3
Proportion of local responders
Determine the proportion of local responders, defined as patients with a worsening of local SCORAD ≥25% over baseline at one day after the second exposure (day 3).
Measured: Baseline to Day 3
Rescue medication use in relation to provocation
Assess rescue medication use in relation to provocation (change in use of topical or systemic rescue medication between the pre-provocation period and the period including and following the two exposure days).
Measured: Baseline to Day 3
Safety and tolerability
Assess the safety and tolerability of local aeroallergen application in adults with atopic dermatitis by determining the number of participants with at least one adverse event related to the local aeroallergen provocation.
Measured: From first exposure through follow-up on Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
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
- Model description
- In this intra-participant split-body design, each participant receives localized grass pollen allergen exposure on one forearm and localized placebo exposure on the contralateral forearm. Participants are randomized to the left-right allocation, which remains unchanged across both exposure days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918586
- Sponsor's protocol ID
- 26-01 AIR-AD
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Localized Aeroallergen Exposure Induced Skin Reaction in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07918586
- Acronym / sponsor ID
- 26-01 AIR-AD
- Conditions
- Atopic Dermatitis
- Keywords
- Aeroallergen exposure, Grass pollen
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Collaborators
- Hannover Medical School
- Study start
- Dec 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 5 Nov 2026 (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 pilot study evaluates skin reactions following localized aeroallergen exposure in adults with atopic dermatitis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- In this intra-participant split-body design, each participant receives localized grass pollen allergen exposure on one forearm and localized placebo exposure on the contralateral forearm. Participants are randomized to the left-right allocation, which remains unchanged across both exposure days.
| Arm | Type | Receives |
|---|---|---|
| Allocation A | Experimental | Other: Localized grass pollen allergen exposure, Other: Localized placebo exposureLocalized grass pollen allergen exposure on the left forearm and localized placebo exposure on the right forearm. |
| Allocation B | Experimental | Other: Localized grass pollen allergen exposure, Other: Localized placebo exposureLocalized placebo exposure on the left forearm and localized grass pollen allergen exposure on the right forearm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able and willing to give written informed consent.
- Male and female subjects, aged 18-65 years. Women will be considered for inclusion if they are:
- Positive IgE level for grass pollen (Phadia g6, Lieschgras) of at least CAP FEIA class 3 (≥3,50 kU/l) at screening or in previous year.
- Atopic dermatitis fulfilling the UK criteria of AD.
- Local SCORAD for erythema domain 1 or 2 in exposed area (cubital fossa / lower arm).
Key exclusion criteria (21 listed)
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
- 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.
- Positive HIV-1/2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCVAb) test at screening or test not performed.
- Treatment with medication that might interfere with rescue medication for the management of allergic reactions (e.g. beta blocker).
- Topical (skin) steroid treatment (wash out phase: 2 weeks before day 1).
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 |
|---|---|---|
| Localized grass pollen allergen exposureLocalized grass pollen allergen exposure on two consecutive days. | Other | Allocation A, Allocation B |
| Localized placebo exposureLocalized placebo exposure on two consecutive days. | Other | Allocation A, Allocation B |
Primary outcome
Difference in the change of local SCORAD
Time frame: Baseline to Day 3
The primary endpoint is defined as the difference in the change of local SCORAD between the grass pollen-exposed arm and the placebo-exposed arm from baseline to post-provocation assessment. For each subject, the change in local SCORAD will be calculated separately for each arm as follows: ΔSCORAD_grass = local SCORAD_grass (Day 3) - local SCORAD_grass (Baseline); ΔSCORAD_placebo = local SCORAD_placebo (Day 3) - local SCORAD_placebo (Baseline). The primary endpoint is then calculated as: Primary endpoint = ΔSCORAD_grass - ΔSCORAD_placebo.
7 secondary outcomes
Change in total SCORAD
Time frame: Baseline to Day 3
Change in EASI
Time frame: Baseline to Day 3
Change in local IGA
Time frame: Baseline to Day 3
Change in itch intensity
Time frame: Baseline to Day 3
Proportion of local responders
Time frame: Baseline to Day 3
Rescue medication use in relation to provocation
Time frame: Baseline to Day 3
Safety and tolerability
Time frame: From first exposure through follow-up on Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Localized grass pollen allergen exposure in people with Atopic Dermatitis, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 2 sites in Germany.
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 11 inclusion and 21 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens Hohlfeld, Prof. Dr. med. (+49 511 5350-8101, jens.hohlfeld@item.fraunhofer.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the change of local SCORAD (time frame: Baseline to 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 Nov 2026.