Trials / Completed
CompletedNCT01475994
Effect of Pollen Challenges on Dermal Symptoms in Patients With Atopic Dermatitis
Pilot Study to Assess the Effect of Pollen Challenges in an Environmental Challenge Chamber on Dermal Symptoms in Patients With Atopic Dermatitis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Grass pollen : Dactylis glomerata | 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. |
| OTHER | Challenge with clean air | The subjects will be challenged for 4 hours on two consecutive days (Day 1 and Day 2) with clean air. |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2012-03-01
- Completion
- 2012-04-01
- First posted
- 2011-11-22
- Last updated
- 2012-04-05
Source: ClinicalTrials.gov record NCT01475994. Inclusion in this directory is not an endorsement.