Clinical Trials Directory

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

TypeNameDescription
OTHERGrass pollen : Dactylis glomerataThe 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.
OTHERChallenge with clean airThe 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.