- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01471119
Sublingual Immunotherapy in Patients With Atopic Dermatitis
August 16, 2018 updated by: Min Zheng, Zhejiang University
Usefulness and Safety of Sublingual Dermatophagoides Farinae Drops in Patients With Atopic Dermatitis:A Randomized,Double-blind,Placebo-controlled Study.
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
239
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- Second Affiliated Hospital,School of Medicine,Zhejiang University.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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 is the group with maintenance dose of 2 drops of grade 5 Dermatophagoides Farinae and 1 drop of placebo.
|
EXPERIMENTAL: 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 is the group with maintenance dose of one drop of grade 5 Dermatophagoides Farinae and 2 drop of placebo.
|
EXPERIMENTAL: 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 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae.
|
EXPERIMENTAL: Placebo
Placebo Group is the group with maintenance dose of 3 drops of placebo.
|
Placebo Group is the group with maintenance dose of 3 drops of placebo.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
average anesis interval
Time Frame: baseline and 36 week
|
The average duration of last 3 whole anesis interval.
|
baseline and 36 week
|
Rescue medication consumption
Time Frame: 36 week
|
The total sum of rescue medication consumption will be recorded.
|
36 week
|
SCORAD
Time Frame: baseline and 36 week
|
Change of SCORAD will be assessed.
|
baseline and 36 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DLQI
Time Frame: baseline and 36 week
|
Change of Dermatology Life Quality Index will be assessed.
|
baseline and 36 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Min Zheng, Doctor, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (ACTUAL)
June 1, 2015
Study Completion (ACTUAL)
June 1, 2015
Study Registration Dates
First Submitted
November 9, 2011
First Submitted That Met QC Criteria
November 9, 2011
First Posted (ESTIMATE)
November 11, 2011
Study Record Updates
Last Update Posted (ACTUAL)
August 17, 2018
Last Update Submitted That Met QC Criteria
August 16, 2018
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WOLWO-CT-A1.0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atopic Dermatitis
-
Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
-
ShaperonNot yet recruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of Scalp
-
University of California, San FranciscoSanofi; Regeneron PharmaceuticalsRecruitingEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related ConditionsUnited States
-
PfizerRecruitingEczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, UnspecifiedUnited States, Czechia, Canada, Poland
-
AmgenCompletedDermatitis, Atopic DermatitisCanada, United States, Japan
-
Hadassah Medical OrganizationUnknownATOPIC DERMATITIS
-
SanofiCompletedAtopic Dermatitis | Dermatitis AtopicChina
-
SanofiCompletedDermatitis AtopicSaudi Arabia, Kuwait, United Arab Emirates
-
National Institute of Allergy and Infectious Diseases...Atopic Dermatitis Research NetworkCompletedAtopic Dermatitis (AD) | Non-atopic Healthy ControlsUnited States
-
AbbVieRecruiting
Clinical Trials on Dermatophagoides Farinae Drops Group 1
-
RAPHASRecruitingRhinitis, Allergic | Mite Allergy | House Dust Mite RhinitisKorea, Republic of
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Terminated
-
Probelte Pharma S.L.U.RecruitingHouse Dust Mite AllergySpain
-
University of North Carolina, Chapel HillNational Institutes of Health (NIH)WithdrawnHealthy | Asthma | Dermatophagoides Farinae Allergy
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Withdrawn
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Withdrawn
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)WithdrawnAsthma, Allergic
-
Benjamin MedoffNational Institutes of Health (NIH); U.S. Army Medical Research and Development...Recruiting
-
Andrew D. Luster, M.D.,Ph.D.National Institute of Allergy and Infectious Diseases (NIAID)CompletedAsthma | AllergiesUnited States
-
Medical University of ViennaAustrian Science Fund (FWF)CompletedBirch Pollen Allergy | Birch Pollen Related Apple AllergyAustria