Sublingual Immunotherapy in Patients With Atopic Dermatitis
NCT01471119 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 239
Last updated 2018-08-17
Summary
To assess the effect and safety of sublingual Dermatophagoides Farinae Drops in adult patients with atopic dermatitis and allergic sensitization to house dust mites.240 adults age 18 to 60 years with atopic dermatitis(Objective Scoring Atopic Dermatitis, Objective SCORAD from 10 to 40) are going to be enrolled in a randomized,double-blind,placebo-controlled study.Sublingual Dermatophagoides Farinae Drops or placebo is given for 9 months in addition to standard therapy.SCORAD,average anesis interval,rescue medicine and DLQI will be recorded.
Conditions
Interventions
- BIOLOGICAL
-
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.
- BIOLOGICAL
-
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.
- BIOLOGICAL
-
Dermatophagoides Farinae Drops Group 3
Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae.
- BIOLOGICAL
-
Placebo Group is the group with maintenance dose of 3 drops of placebo.
Sponsors & Collaborators
-
Wolwo Bio-pharmaceutical Co. LTD.
collaborator UNKNOWN -
Huashan Hospital
collaborator OTHER -
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
collaborator OTHER -
Peking University Third Hospital
collaborator OTHER -
Tongji Hospital
collaborator OTHER -
First Affiliated Hospital of Suzhou Medical College
collaborator OTHER -
Zhejiang University
lead OTHER
Principal Investigators
-
Min Zheng, Doctor · Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-10-31
- Primary Completion
- 2015-06-30
- Completion
- 2015-06-30
Countries
- China
Study Locations
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