Effect of Pollen Challenges on Dermal Symptoms in Patients With Atopic Dermatitis (Neurop)
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.
|Atopic Dermatitis||Other: Grass pollen : Dactylis glomerata Other: Challenge with clean air|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
|Official Title:||Pilot Study to Assess the Effect of Pollen Challenges in an Environmental Challenge Chamber on Dermal Symptoms in Patients With Atopic Dermatitis|
- 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)
- SCORAD Day 4 and 5 [ Time Frame: Day 1/Baseline vs. 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).
|Study Start Date:||November 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Experimental: Challenge with grass pollen||
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.
|Placebo Comparator: Challenge with clean air||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475994
|Principal Investigator:||Jens Hohlfeld, MD, professor||Fraunhofer Gesellschaft|