A randomized, double blinded, placebo controlled multicenter study for the efficacy and safety of Depigoid® House dust mites (HDM) in patients suf-fering from moderate to severe atopic eczema.
- Conditions
- Moderate to severe atopic eczema with or without rhinitis and/or rhinoconjunctivitis caused by clinical relevant IgE-mediated sensitization against House dust mites (HDM) leading to aggravation of patient’s skin lesions.MedDRA version: 8.1Level: LLTClassification code 10003641Term: Atopic eczema
- Registration Number
- EUCTR2006-003066-34-DE
- Lead Sponsor
- ETI Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1.Patients of both gender aged from 18 up to 65 years
2.Prior to study specific examinations the patient has to give his/her written informed consent
3.At least 2 exacerbations of eczema or permanent skin lesions during the last 2 months
4.Patients have to suffer from atopic eczema (with or without rhinitis and/or rhinoconjunctivitis) impaired by clinical sensitization against House dust mites (HDM) leading to an aggravation of skin lesions. The sensitization against House dust mites (HDM) has to be verified by*
·Symptom aggravation of skin lesions by exposure to House dust mites (HDM) and during winter season
·A positive skin prick test for Dermatophagoides pteronyssinus (Der p) and/or Dermatophagoides farinae (Der f), resulting in a wheal diameter of at least 4 mm > negative control reaction or '++' versus histamine
·Specific IgE for Der p or Der f CAP-RAST > 3
5.The diagnosis atopic eczema has to be verified according to the criteria of Hanifin and Rajka
6.Duration of atopic eczema > 5 years
7.Encasings of bedding and mattress for more than 6 months (or stable environmental control)
*Additionally an atopy patch test with Der p and Der f will be performed in selected study sites but not be used as inclusion criterion
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.The following therapy is not allowed within the last 5 years prior to screening as well as during the study and will prevent the patient from being included into the study:
·Specific Immunotheraphy with House dust mites (HDM)
2.The following therapy is not allowed within within 3 months prior to screening as well as during the study and will prevent the patient from being included into the study:
·Photopheresis
3.The following medications and therapies are not allowed within the last month prior to screening as well as during the study and will prevent the patient from being included into the study:
·Immunosuppressive agents (cyclosporins, mycophenolates)
·Systemic corticosteroids
·UV-therapy, tanning
4.The following medications and therapies are not allowed during the entire study and will lead to the patient being withdrawn:
·b-blocker
·Treatment with substances interfering with the immune system
5.Total SCORAD < 30, documented by digital photography
6.Patients with therapeutically uncontrolled atopic eczema or erythrodermia
7.Patients with 3 consecutive exacerbations within 12-24 hours after immunotherapy
Patients with other known concomitant diseases / treatments
8.Active tuberculosis
9.Acute and chronic inflammatory or infectious diseases at the target organ
10.Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
11.Immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
12.Immune deficiencies
13.Uncontrolled asthma, defined as FEV1 or PEF = 70% of predicted normal value
14.Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
15.Cardiovascular insufficiency or any severe or unstable pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant
16.Malignant disease of any kind during the previous 5 years
17.Abnormal laboratory parameters and vital signs that could increase the risk to the study participant
18.Alcohol, drug or medication abuse within the past year
19.Severe psychiatric or neurologic disorders
Others
20.Patients who are expected to be non-compliant and/or not co-operative
21.Participation in any other clinical study within the last 30 days prior to the start of the study
22.Patients who have already participated in this study
23.Patients who are employees at the investigational site, relatives or spouses of the investigator
24.Any donation of germ cells, blood, organs, or bone marrow during the course of the study
25.Patients who are not contractually capable
Special restrictions for female patients
26.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation
27.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or hysterectomy or are u
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method