Skin Responses and T Cell Immunology After House Dust Mite Exposure in Sensitized Atopic Dermatitis Patients

NCT05019209 | Completed

• 1 other identifier: 21-06 CODES
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief 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 previous studies.

Conditions

Atopic Dermatitis; House Dust Mite Allergy

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber

Secondary Outcomes (15)

• Difference of change in local SCORAD

  Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber

• Change in SCORAD index

  Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber

• Change of itch (VAS)

  Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber

• Increase of the rescue medication use

  Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber

• Change of the DLQI

  Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber

Study Arms (1)

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.

Drug: House Dust Mite Allergen; Other: Allergen-free air

Interventions

House Dust Mite Allergen DRUG

D. pteronyssinus lyophilisate dissolved in 5% sodium chloride solution, spray dried

Exposure to saline-dissolved house dust mite allergen and allergen-free air

Allergen-free air OTHER

No allergen added to room ventilation of allergen challenge chamber

Exposure to saline-dissolved house dust mite allergen and allergen-free air

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to give written informed consent.
• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead
• Hannover Medical School: collaborator

Study Sites (2)

Fraunhofer Institute for Toxicology and Experimental Medicine

Hanover, Lower Saxony, 30625, Germany

Location

Hannover Medical School, Department of Dermatology and Allergy

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (3)

• 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.

  PMID: 27497276 BACKGROUND

• Werfel 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.

  PMID: 26044854 BACKGROUND

• Sager 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.

  PMID: 1373161 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Dust Mite Allergy

Interventions

Antigens, Dermatophagoides

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Study Officials

• Jens M Hohlfeld, Prof. Dr.

  Fraunhofer ITEM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Jens M Hohlfeld

Model Details: 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

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 24, 2021
• Study Start: September 10, 2021
• Primary Completion: February 14, 2022
• Study Completion: February 14, 2022
• Last Updated: October 15, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)