The two main objectives are the identification of molecular and clinical signatures that can serve as diagnostic and/or severity-of-disease markers for AD in flare and remission. And the identification of key immunological and molecular pathways…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The presence of a molecular signature of disease exacerbation in the skin and
peripheral blood of patients with moderate to severe atopic dermatitis will be
assessed using the following parameters:
- Composite scores for disease activity and treatment response and patient
reported outcome measures (PROMS):
o The Six Area, Six Sign Atopic Dermatitis (SASSAD)
o SCORing AD (SCORAD)
o Eczema Area and Severity Index (EASI)
o Investigator Global Assesment (IGA)
o Patient Oriented Eczema Measure (POEM)
o Self-assessed EASI (SA-EASI)
- Biomarkers measured in serum and DBS (Luminex: panel of biomarkers including
TARC, MDC, PARC, IL-22, sE-selectin, sIL-2R and IL-16 based on our previous
findings and somalogics: http://www.somalogic.com/)
- Molecular analysis of gene expression from peripheral blood mononuclear cells
(PBMC)
- Molecular analysis of gene expression from skin biopsies
- Immunohistochemistry skin biopsies
Secondary outcome
*Define the propensity of S. aureus colonization/infection of patients and
association with disease exacerbation
*Define the association with asthma and how severity of atopic dermatitis
correlates with asthma severity
Background summary
Atopic dermatitis (AD) is the most common chronic inflammatory skin disease.
From the patient*s perspective, AD is characterized by itch, pain, sleep loss,
and shame, resulting in a substantially impaired quality of life. Although the
pathogenesis of AD is not fully understood, it is thought to arise from a
combination of genetic, epigenetic, and environmental factors. Using a
so-called *systems medicine approach* we propose to unravel these complex
interactions in order to better understand the specific pathways leading to
disease.
Study objective
The two main objectives are the identification of molecular and clinical
signatures that can serve as diagnostic and/or severity-of-disease markers for
AD in flare and remission. And the identification of key immunological and
molecular pathways that are associated with disease exacerbation, and thereby
identify novel putative therapeutic targets.
Study design
Longitudinal observational study, where blood samples, skin biopsies, dried
blood spots, skin swabs and clinical parameters will be prospectively collected
for a duration of one year per patient, and the data will be analysed using the
systems medicine approach.
Study burden and risks
Study participants with a diagnosis of AD will be asked to donate blood samples
and fill in quiestionairres during 7 control visits to the outpatient
clinic.The blood draw will coincide with a blood draw that is necessary for
clinical purposes.
During four of these visits skin swabs, skin strips, and a dried blood spots
will be obtained.
During three of these visits a set of two 4mm biopsies (lesional and
non-lesional AD skin) will be performed.
When the patient experiences a flare during the follow-up of one year, that
does not coincide with one of the standard visits, the patient will be offered
an extra visit, with the additional option of donating an extra set of biopsies.
The burden of participation relies mainly on undergoing skin biopsies, dried
blood spots, extra blood draws and filling in the questionnaires. Performing a
skin biopsy entails a slight risk of haemorrhage and infection. Over the past
years, no SAE's were observed in patients that had biopsies taken for the
Biobank skin. A small scar at the site of biopsy will gradually fade in colour
over time. No biopsies will be taken from the face, neck or the cleavage
regions. Performing a fingerprick for collecting a DBS entails a minimal risk
of infection.
Patients do not directly benefit from participation.
MilsteinBuilding, GrantaPark 1
Cambridge CB21 6GH
GB
MilsteinBuilding, GrantaPark 1
Cambridge CB21 6GH
GB
Listed location countries
Age
Inclusion criteria
* adults (*18 years of age);and for:
* group a (n<=30): diagnosis of AD (according to the criteria of Hanifin and Raijka) with a SASSAD score over 15 at time of inclusion, with an uncontrolled AD using a maintenance dose of local topical steroids as mentioned in the outpatient clinic protocol. These patients need oral immunosuppressive drugs to control their AD
*group b(n<=30): diagnosis of AD (according to the criteria of Hanifin and Raijka) with a SASSAD score over 15 at time of inclusion, with a controlled AD using a maintenance dose of local topical steroids as mentioned in the outpatient clinic protocol
*group c(n<=15): diagnosis of AD (according to the criteria of Hanifin and Raijka) with a SASSAD score <15 at time of inclusion
*group d (n<=15): healthy participants without a history of AD, allergic rhinitis or asthma.
Exclusion criteria
* on systemic therapy at time of recruitment
* previous receipt of any investigational agent within 4 weeks prior to recruitment or within 5 half-lives of the investigational agent, whichever is longer
*evidence of other skin conditions, including, but not limited to, T-cell lymphoma or allergic contact dermatitis
*not willing to be biopsied;group d: a history of AD, allergic rhinitis or asthma.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52918.041.15 |