ProRad-Study
Welcome to ProRaD Study!
Atopic Dermatitis Study: ProRaD:
Prospective longitudinal study to investigate the Remission phase in patients with Atopic Dermatitis (AD) and other allergy-associated diseases such as asthma, food allergies and allergic rhinitis (hay fever).
Study Objective:
- better understanding of the mechanisms influencing the course of AD and allergic diseases
- better characterization of the broad clinical spectrum
- development of clinically relevant and validated biomarkers
- Development of new approaches for the prevention and treatment of atopic dermatitis and associated diseases
Practical procedure of the study:
- Centers in Germany: 1 study visit/year over 5 years to monitor individual disease progression, duration/visit approx. 2 hrs.
- Centers in Switzerland: 3 visits in the first 3-4 weeks, then 1 visit per year over 5 years to observe the individual course of the disease with a duration of 2 hours per visit.
- Patient questionnaires, physical examination,
- optional: collection of blood/ skin swabs/ if necessary skin biopsy
Thank you for your interest!
We are very pleased about your participation in the study and your valuable support!
Study background
While the pH value could be influenced only slightly by the applied creams, especially in healthy individuals, it was shown that a high bacterial density of S. aureus was only found within a relatively small pH value range (pH 5.7-6.2). In those suffering from atopic eczema, no significantly higher pH values were found at baseline, but in some cases higher amounts of Staphylococcus aureus were found on the skin. In those patients who already had a high concentration at the beginning of the study period, the clinical picture worsened significantly during the study period.
“We were able to trace for the first time in a longitudinal study how the skin microbiome evolves in relation to physiological parameters and symptom severity of atopic eczema over the course of treatment with different skin lotions,” said Claudia Hülpüsch, scientist at UNIKA-T and first author of the study. The coincidence between high bacterial counts and severe expression of disease symptoms has already been scientifically proven several times. However, it has now been shown for the first time that large numbers of Staphylococcus aureus bacteria predict the development of disease symptoms. Further studies are needed to confirm the robustness of the results. The evaluation of our CK-CARE data and biobank in relation to the skin microbiome will provide further answers here. Claudia Traidl-Hoffmann, spokesperson for CK-CARE and lead author of the study, adds, “If confirmed, patients could benefit enormously from better predictability of therapeutic interventions.”
Publication:
Skin pH dependent Staphylococcus aureus abundance as predictor for increasing atopic dermatitis severity.
Hülpüsch C, Tremmel K, Hammel G, Bhattacharyya M, de Tomassi A, Nussbaumer T, Neumann AU, Reiger M, Traidl-Hoffmann C. Allergy. 2020 Jun 20.
doi: 10.1111/all.14461. Online ahead of print. PMID: 32562575
“What can we learn from the natural history of allergic diseases?”
The ProRaD study is a multicenter (5 centers in Germany and Switzerland) observational study with the collection of biomaterials (blood, tissue and skin smears).
The ProRaD study is designed to help:
-
to improve the understanding of mechanisms influencing the development and course of atopic dermatitis and accompanying allergic diseases
- to better characterize the sometimes very different clinical picture (so-called “phenotype”).
- to develop clinically relevant and validated biomarkers
- to develop new approaches for the prevention and treatment of atopic dermatitis and associated diseases.
Studienablauf
- Patients with atopic dermatitis/AD (currently symptomatic or history).
How big is the time investment?
- Centers in Germany: 1 study visit per year over 5 years to monitor individual disease progression.
- Centers in Switzerland: two additional visits 10-14 days and 18-21 days after the initial presentation.
- Duration per visit approx. 2 h. To shorten the time, you can read through and complete the questionnaire at home in advance, and all questions will be discussed in person at your appointment.
What happens at the appointment?
- Patient questionnaires are filled out
- Physical examination is performed
- optional:
- Blood draw to isolate and examine DNA and cells& messengers important to atopic dermatitis.
- Skin swabs for examination of microorganisms that may affect atopic dermatitis
- Adults, if necessary, small tissue samples of affected skin for microscopic examination of cells and messenger substances typical for the disease and genetic information.
and messenger substances as well as genetic information (RNA) in the skin.
(Personal) Benefits:
- Support of research (see goals home page)
- Detailed discussion of personal medical history, identification of trigger factors as well as therapy optimization with physician specialized in neurodermatitis possible.
Questions & Answers
Where is the study data managed?
The study data will be managed at the Clinical Trial Unit of the Cantonal Hospital St. Gallen.
The CTU is a multidisciplinary competence center for clinical trials at the Cantonal Hospital St. Gallen. This competence center promotes patient-oriented clinical research and provides infrastructure and human resources for this purpose. For our ProRaD study, all (anonymized) patient data, questionnaires, etc. are managed electronically there in accordance with data protection regulations using special web-based software (SecuTrial).
How is the study funded?
The study is conducted by CK-CARE (Christine Kühne – Center for Allergy Research and Education) based in Davos, Switzerland. CK-CARE is a project of the Kühne-Stiftung. Participation in the study, including all examinations and tests, is free of charge for study participants.
What are biomarkers?
Biomarkers are defined by the WHO as any substance, structure or process that can be measured in the body or its products and can influence or predict the occurrence and/or progression of a disease. A biomarker should be objectively measurable and serve as an indicator of normal biological or pathological processes or pharmacological response to therapy.
Do you have any other questions?
Please contact your nearest CK-CARE study team.
