Sublingual Immunotherapy in Patients With Atopic Dermatitis
NCT ID: NCT01471119
Last Updated: 2018-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
239 participants
INTERVENTIONAL
2011-10-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dermatophagoides Farinae Drops Group 1
Dermatophagoides Farinae Drops Group 1 is the group with maintenance dose of 2 drops of grade 5 Dermatophagoides Farinae and 1 drop of placebo.
Dermatophagoides Farinae Drops Group 1
Dermatophagoides Farinae Drops Group 1 is the group with maintenance dose of 2 drops of grade 5 Dermatophagoides Farinae and 1 drop of placebo.
Dermatophagoides Farinae Drops Group 2
Dermatophagoides Farinae Drops Group 2 is the group with maintenance dose of one drop of grade 5 Dermatophagoides Farinae and 2 drops of placebo.
Dermatophagoides Farinae Drops Group 2
Dermatophagoides Farinae Drops Group 2 is the group with maintenance dose of one drop of grade 5 Dermatophagoides Farinae and 2 drop of placebo.
Dermatophagoides Farinae Drops Group 3
Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae.
Dermatophagoides Farinae Drops Group 3
Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae.
Placebo
Placebo Group is the group with maintenance dose of 3 drops of placebo.
Placebo
Placebo Group is the group with maintenance dose of 3 drops of placebo.
Interventions
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Dermatophagoides Farinae Drops Group 1
Dermatophagoides Farinae Drops Group 1 is the group with maintenance dose of 2 drops of grade 5 Dermatophagoides Farinae and 1 drop of placebo.
Dermatophagoides Farinae Drops Group 2
Dermatophagoides Farinae Drops Group 2 is the group with maintenance dose of one drop of grade 5 Dermatophagoides Farinae and 2 drop of placebo.
Dermatophagoides Farinae Drops Group 3
Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae.
Placebo
Placebo Group is the group with maintenance dose of 3 drops of placebo.
Eligibility Criteria
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Inclusion Criteria
* Mild to moderate AD ( \[SCORAD\] 1O-40)
* The results of skin prick tests with dermatophagoides farinae allergen extracts preparation is positive(≥2+)
* Written informed consent by the subject or legal guardian.
* Female patients of child-bearing potential must be negative pregnant test on screening and use an appropriate method of contraception.
Exclusion Criteria
* Pregnant, breastfeeding women or women planned to pregnant within 1 year.
* Have concurrent skin disease that it could interfere with the study evaluation.
* Were treated with antihistamines or topical therapy within 7 days of randomization.
* Have received systemic corticosteroids,leukotriene receptor antagonists or immunosuppressants within 4 weeks of randomization.
* Have received phototherapy (e.g. UVA, UVB) within 4 weeks of randomization.
* Have a history of immune suppressed diseases(malignant tumor or infection of HIV), autoimmune disease or tuberculosis.
* Patients with impaired liver function (aspartate aminotransferase and/ or alanine aminotransferase levels 1.5 times the upper limit of normal), impaired renal function(serum creatinine\>normal value) or other severe diseases.
* Bronchial asthma patients who need treatments with corticosteroids and or β agonists(including injection, oral administration or inhalation) regularly.
* Patients who need to take β-blockers during research.
* Have received investigational drugs within 3 months prior to randomization or planned use of other investigational drugs during participation in this study.
* Have received immunotherapy with dust mite preparation within 3 years prior to randomization.
* Patients with severe mental disorders.
18 Years
60 Years
ALL
No
Sponsors
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Wolwo Bio-pharmaceutical Co. LTD.
UNKNOWN
Huashan Hospital
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Peking University Third Hospital
OTHER
Tongji Hospital
OTHER
First Affiliated Hospital of Suzhou Medical College
OTHER
Zhejiang University
OTHER
Responsible Party
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Min Zheng
Director of dermatology department,Professor
Principal Investigators
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Min Zheng, Doctor
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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Second Affiliated Hospital,School of Medicine,Zhejiang University.
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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WOLWO-CT-A1.0
Identifier Type: -
Identifier Source: org_study_id
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