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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis; Allergy Pollen
• Intervention / Treatment: Drug: 'Eucerin AtopiControl Lotion' (for the body); Other: Allergen challenge chamber

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Fraunhofer ITEM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Women will be considered for inclusion if they are: not pregnant, as confirmed by pregnancy test (see flow chart) and not nursing.

Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after the last pollen challenge -, implants, injectables, combined oral contraceptives, hormonal Intra Uterine Devices (IUD) or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).

• For patient groups 1 and 2: Positive Immunglobulin E (IgE) level for Dactylis glomerata of at least ImmunoCAP fluoroenzyme immunoassay (CAP FEIA) class 3 at screening or within the last 12 months.
• atopic dermatitis fulfilling the United Kingdom (UK) criteria of AD
• SCORAD index between 20 and 50 points.
• Forced expiratory Volume in 1 second (FEV1) ≥ 80% pred. at screening.
• Smokers or non-smokers
• Applicable only for patients of the control group: No IgE-sensitization to grass pollen (including Dactylis glomerata)

Exclusion Criteria:

• Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease.
• Asthma other than mild asthma which is treated with short acting beta-2-agonists only and which is controlled according to the current GINA (Global Initiative for Asthma) guidelines
• Clinically relevant abnormalities in hematology or blood chemistry at screening.
• Positive Human Immunodeficiency Virus Antibody (HIV-1/2Ab), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV-Ab) test at screening.
• Treatment with medication that might interfere with rescue medication for anaphylactic reactions (e.g. beta blocker).
• Topical steroid treatment of air exposed skin (wash out phase: 2 weeks)
• Topical calcineurin inhibitor treatment of air exposed skin (wash out phase: 2 weeks)
• Ultraviolet (UV) radiation treatment (wash out phase: 4 weeks)
• Systemic immunosuppression treatment (steroids, cyclosporine, azathioprine, Mycophenolate Mofetil (MMF); wash out phase: 4 weeks)
• Treatment with antihistamines (wash out phase: 1 week)
• Specific immunotherapy (SIT) with grass pollen allergens within the last 5 years
• Diastolic blood pressure above 95 mmHg.
• Febrile illness within 2 weeks prior to screening.
• Alcohol or drug abuse within 12 month prior to screening.
• Regular daily consumption of more than 1 liter of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form.
• Participation in another clinical trial 30 days prior to enrolment.
• Risk of non-compliance with study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AD, sensitized, treated; Allergen challenge chamber and Treatment for 12 day with 'Eucerin AtopiControl Lotion' (for the body) and 'Eucerin AtopiControl facial cream' (for the face): 1,2 g twice daily.	Drug: 'Eucerin AtopiControl Lotion' (for the body); Treatment with Eucerin AtopiControl Lotion; Other Names: 'Eucerin AtopiControl facial cream' (for the face); Two 4h-challenges with grass pollen on two consecutive days; Other: Allergen challenge chamber; Exposure to Dactylis glomerata pollen in an environmental challenge chamber
Experimental: AD, not sensitized, not treated; Allergen challenge chamber	Other: Allergen challenge chamber; Exposure to Dactylis glomerata pollen in an environmental challenge chamber
Experimental: AD, sensitized, not treated; Allergen challenge chamber	Other: Allergen challenge chamber; Exposure to Dactylis glomerata pollen in an environmental challenge chamber

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCORAD Day 3	Difference of change in objective SCORAD in treated versus untreated patients	Day 3: pre- 4 hour-challenge with grass pollen and post-4 hour-challenge with grass pollen

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCORAD Day 1,2,4,5	Difference of change in objective SCORAD in treated versus untreated patients	Day 1,2,4,5: pre- 4 hour -challenge with grass pollen and post-4 hour-challenge with grass pollen

Collaborators and Investigators

• Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine
• Collaborators: Hannover Medical School
• Investigators: Principal Investigator: Jens Hohlfeld, MD, Fraunhofer Gesellschaft

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): April 25, 2018
• Study Completion (Actual): April 25, 2018

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 11, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Otorhinolaryngologic Diseases; Skin Diseases, Genetic; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Skin Diseases, Eczematous; Rhinitis, Allergic; Rhinitis; Dermatitis; Eczema; Rhinitis, Allergic, Seasonal; Dermatitis, Atopic
• Other Study ID Numbers: 16-09 Neurop 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No