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Effect of Pollen Challenges on Dermal Symptoms in Patients With Atopic Dermatitis

NCT01475994 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2012-04-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hannover Medical School

    collaborator OTHER

  • Fraunhofer-Institute of Toxicology and Experimental Medicine

    lead OTHER

Principal Investigators

  • Jens Hohlfeld, MD, professor · The Fraunhofer-Gesellschaft

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-03-31
Completion
2012-04-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01475994 on ClinicalTrials.gov