The present study investigates the reaction of the skin upon exposure to house dust mite (HDM) in patients with atopic dermatitis who have antibodies against HDM in the blood. A further aim is to assess nasal symptoms after exposure to HDM in an allergen challenge chamber and compare the results with data from previous studies.
Atopic dermatitis (AD) is a chronic skin disease characterized by a relapsing course and typical clinical manifestation with itchy, eczematous lesions. The majority of AD patients reveals elevated IgE serum levels (\> 100kU / L), which classifies the disease as extrinsic AD. Mostly, the IgE is directed against aeroallergens like pollen and house dust mite (HDM). These allergens may contribute pronouncedly to the relapsing character of the disease. Of note, it was already shown in the 1920s that avoiding aeroallergens by sleeping in an allergen-free chamber has a positive influence not only on the symptoms of asthma but also on the skin condition in AD patients. However, a recent study was the first showing that challenge chamber exposure to airborne grass pollen allergens can cause a clinical worsening of the skin condition in sensitized AD patients. These standardized settings in the Fraunhofer Allergen Challenge Chamber can conduce as a model for the investigation of the impact on other allergens on AD patients. For the perennial allergen HDM, Sager et al. investigated the epicutaneous application of HDM allergens in sensitized AD patients. It led to an aggravation of the eczematous lesions through a T-cell-mediated reaction. The binding of the HDM allergen to specific IgE-Fc receptors on Langerhans cells leads to the proliferation of specific T cells in the skin and a proinflammatory signaling. Until now, however, airborne HDM allergen exposure has not been shown to cause aggravation of AD in any controlled setting. This study aims to answer the question of the extent to which standardized exposure of AD patients with HDM has an impact on objective, subjective and in vitro disease parameters.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
23
D. pteronyssinus lyophilisate dissolved in 5% sodium chloride solution, spray dried
No allergen added to room ventilation of allergen challenge chamber
Fraunhofer Institute for Toxicology and Experimental Medicine
Hanover, Lower Saxony, Germany
Hannover Medical School, Department of Dermatology and Allergy
Hanover, Lower Saxony, Germany
Change in the objective SCORAD
SCORAD is an established score taking severity of typical lesions, the extent of involvement of the skin and the subjective items itch and sleeplessness into account. The subjective symptoms will be assessed referring to the period of time of the past three days. The objective SCORAD is based on the calculation of the SCORAD mentioned above, but without the subjective parameters itch and sleeplessness
Time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Difference of change in local SCORAD
SCORAD is an established score taking severity of typical lesions, the extent of involvement of the skin and the subjective items itch and sleeplessness into account. The subjective symptoms will be assessed referring to the period of time of the past three days. The objective SCORAD is based on the calculation of the SCORAD mentioned above, but without the subjective parameters itch and sleeplessness
Time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Change in SCORAD index
SCORAD is an established score taking severity of typical lesions, the extent of involvement of the skin and the subjective items itch and sleeplessness into account. The subjective symptoms will be assessed referring to the period of time of the past three days. The objective SCORAD is based on the calculation of the SCORAD mentioned above, but without the subjective parameters itch and sleeplessness
Time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Change of itch (VAS)
The subjects rate their actual skin itch on a visual analog scale (VAS). The VAS is an unmarked line with a length of 10cm. The left end of the line is labeled "no itch" and the right end is labeled "worst itch imaginable". Each time the subjects assess their itch they have to mark the line at the position they feel their symptoms are at this moment in relation to the symptoms described at both ends of the line
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Increase of the rescue medication use
Rescue medications are class II topical glucocoticosteroids and topical calcineurin inhibitors
Time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Change of the DLQI
The dermatological life quality index (DLQI) is a valid measuring instrument that represents the health-related quality of life in skin diseases. Each of the questions is rated with 0-3 points, from which the total value is added
Time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Change of IGA
The Investigator's Global Assessment scale (IGA) score provides information about the overall appearance of the lesions at a specific point in time. It is not necessary that all characteristics are included under Morphological Description. The score is divided into 5 levels from clear to severe.
Time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Change of EASI
The Eczema Area and Severity Index (EASI) is another score evaluating the Skin in AD patients. The body surface is divided according to percentage. To assess the severity of the lesions, they are analyzed in detail in terms of erythema, infiltration, excoriation and lichenification. Values between 0 and 72 can be calculated.
Time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Differences of skin related severity scores between clean- and HDM exposure
skin behaviour rating between study groups
Time frame: Day 1 to Day 6
Difference of AUC2-4hTNSS between clean- and HDM exposure
Mean over two hours of subjective nasal symptoms between study groups
Time frame: Day 1 to Day 6
Difference of AUC2-4hTNSS between HDM exposure
Mean over two hours of subjective nasal symptoms between exposure sessions
Time frame: Day 1 to Day 6
Difference of maximum TNSS between clean-air and HDM exposure
Maximum degree of subjective nasal symptoms between study groups
Time frame: Day 1 to Day 6
Difference of maximum TNSS between HDM exposure
Nasal symptoms will be evaluated by the subject prior to and every 20 minutes during allergen challenge according to the 4 point severity scale including nasal congestion, rhinorrhea, nasal itching and sneezing. Each symptom can be scored from 0 (no symptoms) to 3 (severe symptoms). Scores range from 0 to 12.
Time frame: Day 1 to Day 6
Difference of nasal secretion weight per hour between clean-air and HDM exposure
Subjects will receive pre-weighed sachets of handkerchiefs which will be weighed again after exposure in the allergen challenge chamber.
Time frame: Day 1 to Day 6
Difference of nasal secretion weight per hour between HDM exposure
Subjects will receive pre-weighed sachets of handkerchiefs which will be weighed again after exposure in the allergen challenge chamber.
Time frame: Day 1 to Day 6
Change in nasal secretion weight between pre-challenge and the sum of post challenge nasal secretion weights of both allergen-free air exposures
Subjects will receive pre-weighed sachets of handkerchiefs which will be weighed again after exposure in the allergen challenge chamber.
Time frame: Day 1 to Day 6