Sublingual Immunotherapy in Patients With Atopic Dermatitis
Usefulness and Safety of Sublingual Dermatophagoides Farinae Drops in Patients With Atopic Dermatitis:A Randomized,Double-blind,Placebo-controlled Study.
1 other identifier
interventional
239
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 9, 2011
CompletedFirst Posted
Study publicly available on registry
November 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedAugust 17, 2018
August 1, 2015
3.7 years
November 9, 2011
August 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (1)
DLQI
baseline and 36 week
Study Arms (4)
Dermatophagoides Farinae Drops Group 1
EXPERIMENTALDermatophagoides 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
EXPERIMENTALDermatophagoides 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 3
EXPERIMENTALDermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae.
Placebo
EXPERIMENTALPlacebo Group is the group with maintenance dose of 3 drops of placebo.
Interventions
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 is the group with maintenance dose of one drop of grade 5 Dermatophagoides Farinae and 2 drop of placebo.
Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae.
Eligibility Criteria
You may qualify if:
- Patients of either sex ,aged from 18 to 60 years. Diagnosed of atopic dermatitis.
- 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.
You may not qualify if:
- Dust mites are not the primary allergens.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhejiang Universitylead
- Wolwo Bio-pharmaceutical Co. LTD.collaborator
- Huashan Hospitalcollaborator
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- Peking University Third Hospitalcollaborator
- Tongji Hospitalcollaborator
- First Affiliated Hospital of Suzhou Medical Collegecollaborator
Study Sites (1)
Second Affiliated Hospital,School of Medicine,Zhejiang University.
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Min Zheng, Doctor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of dermatology department,Professor
Study Record Dates
First Submitted
November 9, 2011
First Posted
November 11, 2011
Study Start
October 1, 2011
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
August 17, 2018
Record last verified: 2015-08