Effect of Pollen Challenges on Dermal Symptoms in Patients With Atopic Dermatitis (Neurop)
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|ClinicalTrials.gov Identifier: NCT01475994|
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : April 5, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Other: Grass pollen : Dactylis glomerata Other: Challenge with clean air||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (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|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||April 2012|
|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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475994
|Principal Investigator:||Jens Hohlfeld, MD, professor||Fraunhofer Gesellschaft|