NCT03315611

Study to Assess the Effect of "Eucerin AtopiControl" on Dermal Symptoms in Patients With Atopic Dermatitis

Study to Assess the Effect of "Eucerin AtopiControl" on Dermal Symptoms in Patients With Atopic Dermatitis After Challenges With Grass Pollen in the Fraunhofer Allergen Challenge Chamber

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the effect of 'Eucerin AtopiControl LOTION' and 'Eucerin AtopiControl facial cream' on dermal symptoms in patients with Atopic Dermatitis (AD) after two 4 h challenges with grass pollen on two consecutive days. In addition, this clinical study with exposure of Dactyls glomerate-sensitized Patients with AD shall be used to compare the skin response with AD Patients not-sensitized to Dactylis glomerata to understand the specificity of the grass pollen exposure.

Detailed description

After the screening assessments the subject's whole skin will be treated for a period of 12 days with either 'Eucerin AtopiControl LOTION' or 'Eucerin AtopiControl facial cream' or will receive no treatment until Day 1 of the study. All patients will be challenged for 4 hours on two consecutive days (Day1 and 2) with 4000 pollen grains/m³ of Dactylis glomerata pollen. In this study approximately 9 subjects will be placed in the Environmental Exposure Chamber (ECC) at a time. At screening a blood sample will be taken for determination mutations of genes encoding for skin barrier proteins (e.g. filaggrin mutation). At day 1 and day 5 blood samples (serum) will be taken for biomarker assessments and lymphocyte proliferation assays (peripheral blood). The severity of atopic dermatitis will be rated (blinded observer, trained dermatologist) applying the 'SCORing Atopic Dermatitis (SCORAD) index, the objective SCORAD, local SCORAD and Investigator Global assessment (IGA). Assessment of itch and sleeplessness referring to the past 24 hous will be done by a blinded observer on each day including baseline assessments.

Conditions

• Atopic Dermatitis
• Allergy Pollen

Interventions

Type	Name	Description
DRUG	'Eucerin AtopiControl Lotion' (for the body)	Treatment with Eucerin AtopiControl Lotion
OTHER	Allergen challenge chamber	Exposure to Dactylis glomerata pollen in an environmental challenge chamber

Timeline

• Start date: 2017-10-02
• Primary completion: 2018-04-25
• Completion: 2018-04-25
• First posted: 2017-10-20
• Last updated: 2018-05-14

Locations

1 site across 1 country: Germany