Localized Aeroallergen Exposure in Atopic Dermatitis
NCT07918586, Not applicable, Not yet recruiting, Fraunhofer-Institute of Toxicology and Experimental Medicine
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Localized Aeroallergen Exposure in Atopic Dermatitis | ClinicalTrials.gov |
| NCT number | NCT07918586 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 15 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fraunhofer-Institute of Toxicology and Experimental Medicine | ClinicalTrials.gov |
| Conditions | Atopic Dermatitis | ClinicalTrials.gov |
| Interventions | Localized grass pollen allergen exposure, Localized placebo exposure | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Difference in the change of local SCORAD | 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. | ClinicalTrials.gov |
| Secondary | Change in total SCORAD | Baseline to Day 3 | Assess the change in total SCORAD between pre-provocation baseline and one day after the second exposure (day 3). | ClinicalTrials.gov |
| Secondary | Change in EASI | Baseline to Day 3 | 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. | ClinicalTrials.gov |
| Secondary | Change in local IGA | Baseline to Day 3 | Evaluate disease severity by the change in local IGA between baseline and one day after the second exposure (day 3). | ClinicalTrials.gov |
| Secondary | Change in itch intensity | Baseline to Day 3 | Evaluate itch intensity related to provocation by the change in itch VAS between baseline and one day after the second exposure (day 3). | ClinicalTrials.gov |
| Secondary | Proportion of local responders | Baseline to Day 3 | 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). | ClinicalTrials.gov |
| Secondary | Rescue medication use in relation to provocation | Baseline to Day 3 | 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). | ClinicalTrials.gov |
| Secondary | Safety and tolerability | From first exposure through follow-up on Day 7 | 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. | ClinicalTrials.gov |
| Other | Changes in skin microbiome composition over time | Baseline to Day 3 | 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. | ClinicalTrials.gov |
| Other | Changes in selected serum proteins | Baseline to Day 3 | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)