Status:
COMPLETED
Study to Assess the Effect of "Eucerin AtopiControl" on Dermal Symptoms in Patients With Atopic Dermatitis
Lead Sponsor:
Fraunhofer-Institute of Toxicology and Experimental Medicine
Collaborating Sponsors:
Hannover Medical School
Conditions:
Atopic Dermatitis
Allergy Pollen
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ch...
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2018
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03315611
Start Date
October 2 2017
End Date
April 25 2018
Last Update
May 14 2018
Active Locations (1)
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1
Fraunhofer ITEM
Hanover, Lower Saxony, Germany, 30625