Atopic DermatitisCODESNCT05019209
Skin Responses and T Cell Immunology After House Dust Mite Exposure in Sensitized Atopic Dermatitis Patients
A study testing House Dust Mite Allergen and Allergen-free air in people with Atopic Dermatitis and House Dust Mite Allergy, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 2 sites in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis, House Dust Mite Allergy
- What is being tested?
- House Dust Mite Allergen and Allergen-free air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesGermany
- Study dates
- 10 Sep 2021to 14 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to give written informed consent.
- Male and female subjects, aged 18-65 years. 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 meets 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 start of the study until at least 72 hours after the last study visit -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- Positive IgE level for HDM of at least CAP FEIA class 3 (≥3,50 kU/l) at screening or in previous year.
Show all 13Show fewer
- Atopic dermatitis fulfilling the UK criteria of AD
- SCORAD index between 20 and 50 points.
- Positive self-history regarding poor skin condition during fall and winter months and allergic rhinitis and/or conjunctivitis in situations of significant HDM exposure (e.g., dusting).
- FEV1 ≥ 80% pred. at screening.
- Total Nasal Symptom Score (TNSS) of ≤ 3 prior to entering the chamber at visit 2.
- Smokers or non-smokers.
- BMI ≥18 and ≤ 35.
Who cannot join
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs or lung function at screening visit , which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study
- 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 guidelines
- Subject with concomitant allergies to seasonal aeroallergens which become active (i.e., grass, trees, weeds, rye; defined as being symptomatic to aeroallergens within the past 2 years or within the past 2 allergy seasons) during the individual study participation.
- Positive HIV-1/2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV-Ab) test at screening or test not performed.
- Treatment with medication that might interfere with rescue medication for anaphylactic reactions (e.g. beta blocker).
Show all 22Show fewer
- Topical steroid treatment (wash out phase: 2 weeks before day 1)
- Topical calcineurin inhibitor treatment (wash out phase 2 weeks before day 1)
- UV radiation treatment (wash out phase 4 weeks before day 1)
- Systemic immunosuppression treatment (steroids, biologics, e.g. dupilumab, JAK-Inhibitors, cyclosporine, azathioprine, Mycophenolat Mofetil (MMF); wash out phase 4 weeks and 3 months, respectively, before day 1.
- Treatment with antihistamines (wash out phase 1 week).
- Unstable AD during Screening (SCORAD difference of >10 points from Visit 1 to Visit 2)
- Diastolic blood pressure above 95 mmHg.
- Acute respiratory infection 2 weeks prior to screening visit.
- 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 enrollment.
- There is a risk of non-compliance with study procedures.
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
- History of an acute infection four weeks prior to the informed consent visit.
- Subject has received previous immunotherapy treatment with any HDM allergen within 3 years prior to screening.
- Subject is receiving ongoing treatment with any specific immunotherapy for other allergies.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Fraunhofer Institute for Toxicology and Experimental Medicine
Hanover, Lower Saxony, 30625
Hannover Medical School, Department of Dermatology and Allergy
Hanover, Lower Saxony, 30625
About this study
Official title: Chamber Exposure with House Dust Mite (HDM) or Allergen-free Air in Atopic Drmatitis Patients with HDM Sensitization to Investigate the Role of Aeroallergen Exposure on Skin Responses and T Cell Immunology
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.
Read the detailed description
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.
- Conditions
- Atopic Dermatitis, House Dust Mite Allergy
- Being tested
- House Dust Mite Allergen, Allergen-free air
- Medical subject headings
- Dermatitis, Atopic, Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
House Dust Mite AllergenDrug
- pteronyssinus lyophilisate dissolved in 5% sodium chloride solution, spray dried
Allergen-free airOther
No allergen added to room ventilation of allergen challenge chamber
| Study group | Role | What they receive |
|---|---|---|
| Exposure to saline-dissolved house dust mite allergen and allergen-free air | Experimental | Subjects are blinded to the sequence of interventions in the allergen challenge chamber (ACC). Overall, subjects will be in the ACC 4 times during the study. Of those, exposure to allergen-free air and HDM is allocated in a 2:2 ratio. Receives: Drug: House Dust Mite Allergen; Other: Allergen-free air |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Day 1 to Day 6
Difference of AUC2-4hTNSS between HDM exposure
Mean over two hours of subjective nasal symptoms between exposure sessions
Measured: Day 1 to Day 6
Difference of maximum TNSS between clean-air and HDM exposure
Maximum degree of subjective nasal symptoms between study groups
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start10 Sep 2021
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects are exposed to house dust mite and allergen-free air in the same sequence. Subjects are blinded to the sequence of house dust mite and allergen-free air exposures
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School
- Responsible party
- Principal investigator, Prof. Dr. Jens Hohlfeld, MD, Fraunhofer-Institute of Toxicology and Experimental Medicine
- Investigators
- Jens M Hohlfeld, Prof. Dr., Principal investigator, Fraunhofer ITEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019209
- Sponsor's protocol ID
- 21-06 CODES
- Acronym
- CODES
- Status last verified
- Jan 2023
- First submitted
- 19 Aug 2021
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Werfel T, Allam JP, Biedermann T, Eyerich K, Gilles S, Guttman-Yassky E, Hoetzenecker W, Knol E, Simon HU, Wollenberg A, Bieber T, Lauener R, Schmid-Grendelmeier P, Traidl-Hoffmann C, Akdis CA. Cellular and molecular immunologic mechanisms in patients with atopic dermatitis. J Allergy Clin Immunol. 2016 Aug;138(2):336-49. doi: 10.1016/j.jaci.2016.06.010.
PubMed 27497276Werfel T, Heratizadeh A, Niebuhr M, Kapp A, Roesner LM, Karch A, Erpenbeck VJ, Losche C, Jung T, Krug N, Badorrek P, Hohlfeld JM. Exacerbation of atopic dermatitis on grass pollen exposure in an environmental challenge chamber. J Allergy Clin Immunol. 2015 Jul;136(1):96-103.e9. doi: 10.1016/j.jaci.2015.04.015. Epub 2015 Jun 1.
PubMed 26044854Sager N, Feldmann A, Schilling G, Kreitsch P, Neumann C. House dust mite-specific T cells in the skin of subjects with atopic dermatitis: frequency and lymphokine profile in the allergen patch test. J Allergy Clin Immunol. 1992 Apr;89(4):801-10. doi: 10.1016/0091-6749(92)90434-4.
PubMed 1373161
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chamber Exposure with House Dust Mite (HDM) or Allergen-free Air in Atopic Drmatitis Patients with HDM Sensitization to Investigate the Role of Aeroallergen Exposure on Skin Responses and T Cell Immunology
- ClinicalTrials.gov ID
- NCT05019209
- Acronym / sponsor ID
- CODES / 21-06 CODES
- Conditions
- Atopic Dermatitis, House Dust Mite Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Collaborators
- Hannover Medical School
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects are exposed to house dust mite and allergen-free air in the same sequence. Subjects are blinded to the sequence of house dust mite and allergen-free air exposures
| Arm | Type | Receives |
|---|---|---|
| Exposure to saline-dissolved house dust mite allergen and allergen-free air | Experimental | Drug: House Dust Mite Allergen, Other: Allergen-free airSubjects are blinded to the sequence of interventions in the allergen challenge chamber (ACC). Overall, subjects will be in the ACC 4 times during the study. Of those, exposure to allergen-free air and HDM is allocated in a 2:2 ratio. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Able and willing to give written informed consent.
- Male and female subjects, aged 18-65 years. 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 meets 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 start of the study until at least 72 hours after the last study visit -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
Key exclusion criteria (22 listed)
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs or lung function at screening visit , which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study
- 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 guidelines
- Subject with concomitant allergies to seasonal aeroallergens which become active (i.e., grass, trees, weeds, rye; defined as being symptomatic to aeroallergens within the past 2 years or within the past 2 allergy seasons) during the individual study participation.
- Positive HIV-1/2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV-Ab) test at screening or test not performed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| House Dust Mite AllergenD. pteronyssinus lyophilisate dissolved in 5% sodium chloride solution, spray dried | Drug | Exposure to saline-dissolved house dust mite allergen and allergen-free air |
| Allergen-free airNo allergen added to room ventilation of allergen challenge chamber | Other | Exposure to saline-dissolved house dust mite allergen and allergen-free air |
Primary outcome
Change in the objective SCORAD
Time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
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
15 secondary outcomes
Difference of change in local SCORAD
Time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Change in SCORAD index
Time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Change of itch (VAS)
Time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Increase of the rescue medication use
Time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Change of the DLQI
Time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Change of IGA
Time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Change of EASI
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
Time frame: Day 1 to Day 6
Difference of AUC2-4hTNSS between clean- and HDM exposure
Time frame: Day 1 to Day 6
Difference of AUC2-4hTNSS between HDM exposure
Time frame: Day 1 to Day 6
Difference of maximum TNSS between clean-air and HDM exposure
Time frame: Day 1 to Day 6
Difference of maximum TNSS between HDM exposure
Time frame: Day 1 to Day 6
Difference of nasal secretion weight per hour between clean-air and HDM exposure
Time frame: Day 1 to Day 6
Difference of nasal secretion weight per hour between HDM exposure
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
Time frame: Day 1 to Day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 27497276Werfel T, Allam JP, Biedermann T, Eyerich K, Gilles S, Guttman-Yassky E, Hoetzenecker W, Knol E, Simon HU, Wollenberg A, Bieber T, Lauener R, Schmid-Grendelmeier P, Traidl-Hoffmann C, Akdis CA. Cellular and molecular immunologic mechanisms in patients with atopic dermatitis. J Allergy Clin Immunol. 2016 Aug;138(2):336-49. doi: 10.1016/j.jaci.2016.06.010.
- Background: PubMed 26044854Werfel T, Heratizadeh A, Niebuhr M, Kapp A, Roesner LM, Karch A, Erpenbeck VJ, Losche C, Jung T, Krug N, Badorrek P, Hohlfeld JM. Exacerbation of atopic dermatitis on grass pollen exposure in an environmental challenge chamber. J Allergy Clin Immunol. 2015 Jul;136(1):96-103.e9. doi: 10.1016/j.jaci.2015.04.015. Epub 2015 Jun 1.
- Background: PubMed 1373161Sager N, Feldmann A, Schilling G, Kreitsch P, Neumann C. House dust mite-specific T cells in the skin of subjects with atopic dermatitis: frequency and lymphokine profile in the allergen patch test. J Allergy Clin Immunol. 1992 Apr;89(4):801-10. doi: 10.1016/0091-6749(92)90434-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens M Hohlfeld, Prof. Dr. principal investigator
Fraunhofer ITEM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing House Dust Mite Allergen and Allergen-free air in people with Atopic Dermatitis and House Dust Mite Allergy, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the objective SCORAD (time frame: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05019209, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.