Determine the frequency, phenotype and function of disorder-related immune cells, or levels of immune molecules in skin and peripheral blood of patients with inflammatory skin diseases, during the active phase of disease prior to and/or at any time…
ID
Source
Brief title
Condition
- Allergic conditions
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To identify the key pathogenic cells, their function, interaction and
production of mediators (e.g. cytokines, chemokines) in inflammatory skin
diseases and to recognize the role of these parameters in the etiopathology and
to what extent they are specific for the different disorders.
2. To assess if the identified putative pathogenic cells are also present in
asymptomatic skin of the same patient (or persist after therapy) or in healthy
normal human skin. If so, the question needs to be answered why these cells are
only locally triggered to cause the disease (e.g. higher quantity of pathogenic
cells, presence of activation factors).
3. To assess if the presence of identified putative pathogenic cells and
mediators correlate with therapy (do they decline in responders and persist in
non-responders), and determine whether different treatment modalities have
differential potential to change the frequency and functional state of those
pathogenic cells and mediators.
4. To identify key disease-specific biomarkers (genetic and protein level) in
blood or skin samples that can accurately predict disease progression or
therapeutic response at an early stage and independent of the therapy modality
used.
Secondary outcome
not applicable
Background summary
Inflammatory skin disorders (including psoriasis, atopic dermatitis, lichen
planus, and contact dermatitis) are related to aberrant function or imbalanced
interaction of immune cells in the skin and may have an (epi)genetic cause. The
majority of patients with inflammatory skin diseases is successfully treated
with standard therapies, yet current treatments (including biologics for
psoriasis and atopic dermatitis) appear not effective in a substantial number
of patients for unknown reasons. Hence, dermatologists would like to know as
early as possible (preferably a priori) whether the applied treatment (or
considered therapy) would provide a good outcome, in order to prevent
unnecessary exposure to ineffective drugs and their side effects and delay
effective treatment with alternative drugs. Therefore, the responsiveness to a
drug (in particular expensive biologics) should be determined as soon as
possible, to refrain nonresponders from that drug at an early stage, and to
keep medical care affordable. Accordingly, there is a high unmet medical need
for identification of biomarkers that can inform which therapies are most
likely to be efficacious for a particular patient. In addition, uncovered key
biomarkers may serve as new targets to improve therapeutic intervention.
Study objective
Determine the frequency, phenotype and function of disorder-related immune
cells, or levels of immune molecules in skin and peripheral blood of patients
with inflammatory skin diseases, during the active phase of disease prior to
and/or at any time under treatment. These data will be compared to
corresponding cells and mediator levels in healthy controls, to understand
their role in the development and resolution of the disease. This study will
identify predictive biomarkers for therapeutic outcome.
Study design
Single center, longitudinal, observational study
Study burden and risks
Subjects participating in the study will not experience any delay, disadvantage
in their medical care nor miss any regular treatment.
Risks associated with skin biopsy taking are bleeding, infection, and scar
formation, all of which are negligible because of the small size of the biopsy.
Vena puncture to draw blood may result in a temporary hematoma at the site of
puncture. Vacuum-mediated sampling of skin fluid from laser-created micro-pores
is optional and requires a time investment of around two hours. There is a
limited risk of blister formation due to the vacuum-assisted fluid sampling,
the sampling area is known to heal without scar tissue and the risk of
infection is negligible. Tape-stripping and saliva sampling are simple,
painless and quick procedures.
The results of this study will have no direct impact on the patient*s
treatment. However, it is important to remember that the knowledge gained may
have an impact on our future practice in the treatment of inflammatory skin
diseases.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Adult (age >=18) patients with inflammatory skin disorders: psoriasis, atopic
dermatitis, lichen planus, or (irritant, allergic, or photo) contact dermatitis
Exclusion criteria
Patients with hypertrophic scars, with keloid, with a history of
hypersensitivity or allergy to local anesthesia, and patients with hemophilia
or other clotting disorders.
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 | NL72248.018.19 |