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| Name | Class |
|---|---|
| Wolwo Bio-pharmaceutical Co. LTD. | UNKNOWN |
| Huashan Hospital | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Peking University Third Hospital |
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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.
SCORAD is composed of skin rash area,severity and subjective symptom including pruritus and sleeping quality.Skin rash area and severity score are objective SCORAD(range from 0 to 83).Subjective SCORAD range from 0 to 20 and total SCORAD range from 0 to 103.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermatophagoides Farinae Drops Group 1 | Experimental | Dermatophagoides Farinae Drops Group 1 is the group with maintenance dose of 2 drops of grade 5 Dermatophagoides Farinae and 1 drop of placebo. |
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| Dermatophagoides Farinae Drops Group 2 | Experimental | Dermatophagoides Farinae Drops Group 2 is the group with maintenance dose of one drop of grade 5 Dermatophagoides Farinae and 2 drops of placebo. |
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| Dermatophagoides Farinae Drops Group 3 | Experimental | Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae. |
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| Placebo | Experimental | Placebo Group is the group with maintenance dose of 3 drops of placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermatophagoides Farinae Drops Group 1 | Biological | Dermatophagoides Farinae Drops Group 1 is the group with maintenance dose of 2 drops of grade 5 Dermatophagoides Farinae and 1 drop of placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| average anesis interval | The average duration of last 3 whole anesis interval. | baseline and 36 week |
| Rescue medication consumption | The total sum of rescue medication consumption will be recorded. | 36 week |
| SCORAD | Change of SCORAD will be assessed. | baseline and 36 week |
| Measure | Description | Time Frame |
|---|---|---|
| DLQI | Change of Dermatology Life Quality Index will be assessed. | baseline and 36 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Zheng, Doctor | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital,School of Medicine,Zhejiang University. | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| OTHER |
| Tongji Hospital | OTHER |
| First Affiliated Hospital of Suzhou Medical College | OTHER |
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| Dermatophagoides Farinae Drops Group 2 | Biological | 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 | Biological | Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae. |
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| Placebo | Biological | Placebo Group is the group with maintenance dose of 3 drops of placebo. |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |