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

NCT03315611 | Completed

• 1 other identifier: 16-09 Neurop 2
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis; Allergy Pollen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• SCORAD Day 1,2,4,5

  Day 1,2,4,5: pre- 4 hour -challenge with grass pollen and post-4 hour-challenge with grass pollen

Study Arms (3)

AD, sensitized, treated

ACTIVE COMPARATOR

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); Other: Allergen challenge chamber

AD, not sensitized, not treated

EXPERIMENTAL

Allergen challenge chamber

Other: Allergen challenge chamber

AD, sensitized, not treated

EXPERIMENTAL

Allergen challenge chamber

Other: Allergen challenge chamber

Interventions

'Eucerin AtopiControl Lotion' (for the body) DRUG

Treatment with Eucerin AtopiControl Lotion

Also known as: 'Eucerin AtopiControl facial cream' (for the face), Two 4h-challenges with grass pollen on two consecutive days

AD, sensitized, treated

Allergen challenge chamber OTHER

Exposure to Dactylis glomerata pollen in an environmental challenge chamber

AD, not sensitized, not treated; AD, sensitized, not treated; AD, sensitized, treated

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead
• Hannover Medical School: collaborator

Study Sites (1)

Fraunhofer ITEM

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases

Study Officials

• Jens Hohlfeld, MD

  The Fraunhofer-Gesellschaft

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The working hypothesis fo this study is, that local treatment with 'Eucerin AtopiControl Lotion' and 'Eucerin AtopiControl Gesichtscreme' compared to no treatment signifixantly reduces the increase of SCORAD that is elicited during challenge in an environmental challenge chamber (ECC) with grass pollen.

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 20, 2017
• Study Start: October 2, 2017
• Primary Completion: April 25, 2018
• Study Completion: April 25, 2018
• Last Updated: May 14, 2018

Record last verified: 2017-10

Locations

DE (1)