An interventional study of Localized grass pollen allergen exposure and Localized placebo exposure in Atopic Dermatitis, sponsored by Fraunhofer-Institute of Toxicology and Experimental Medicine. Not yet recruiting at 2 sites in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Fraunhofer-Institute of Toxicology and Experimental Medicine · Not applicable, Interventional, and Basic science
This pilot study evaluates skin reactions following localized aeroallergen exposure in adults with atopic dermatitis.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 15 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Fraunhofer-Institute of Toxicology and Experimental Medicine is the lead sponsor of 38 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Male and female subjects, aged 18-65 years. Women will be considered for inclusion if they are:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Localized grass pollen allergen exposure on the left forearm and localized placebo exposure on the right forearm.
Other: Localized grass pollen allergen exposure · Other: Localized placebo exposure
Localized placebo exposure on the left forearm and localized grass pollen allergen exposure on the right forearm.
Other: Localized grass pollen allergen exposure · Other: Localized placebo exposure
Localized grass pollen allergen exposure on two consecutive days.
Localized placebo exposure on two consecutive days.
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.
Time frame: Baseline to Day 3
Change in total SCORAD
Assess the change in total SCORAD between pre-provocation baseline and one day after the second exposure (day 3).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: From first exposure through follow-up on Day 7
Changes in skin microbiome composition over time
Exploratory analyses will be performed to characterize biological changes associated with localized grass pollen provocation at the skin level. Skin swabs: Exploratory microbiome endpoints include changes in skin microbiome composition over time, assessed by beta-diversity metrics. For each subject, within-site changes in microbial community composition from baseline to Day 3 will be determined separately for the grass pollen and placebo sites, and the difference in these changes between the two sites will be analyzed. Additional exploratory microbiome endpoints include changes in alpha diversity and exploratory analyses of differential abundance of selected bacterial taxa, where technically feasible.
Time frame: Baseline to Day 3
Changes in selected serum proteins
Blood samples: Exploratory endpoints include changes in selected serum proteins associated with allergic inflammation and AD from baseline to Day 3. Serum proteins will be measured using the Olink Inflammation Panel and reported as NPX (Normalized Protein Expression).
Time frame: Baseline to Day 3
Start is estimated for Dec 2026; primary completion for Apr 2027, 4 months later.
Of 113 non-industry interventional studies with no phase under Dermatitis, Atopic, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 4 months is below that.
Counting every sponsor, half of 182 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Fraunhofer-Institute of Toxicology and Experimental Medicine