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Sublingual Immunotherapy in Patients With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01471119
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : August 17, 2018
Sponsor:
Collaborators:
Wolwo Bio-pharmaceutical Co. LTD.
Huashan Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Peking University Third Hospital
Tongji Hospital
First Affiliated Hospital of Suzhou Medical College
Information provided by (Responsible Party):
Min Zheng, Zhejiang University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: Dermatophagoides Farinae Drops Group 1 Biological: Dermatophagoides Farinae Drops Group 2 Biological: Dermatophagoides Farinae Drops Group 3 Biological: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Usefulness and Safety of Sublingual Dermatophagoides Farinae Drops in Patients With Atopic Dermatitis:A Randomized,Double-blind,Placebo-controlled Study.
Study Start Date : October 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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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.
 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.
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.
 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.
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.
 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.
Experimental: Placebo
Placebo Group is the group with maintenance dose of 3 drops of placebo.
 Biological: Placebo
Placebo Group is the group with maintenance dose of 3 drops of placebo.


Outcome Measures
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Primary Outcome Measures :
  1. average anesis interval [ Time Frame: baseline and 36 week ]
    The average duration of last 3 whole anesis interval.

  2. Rescue medication consumption [ Time Frame: 36 week ]
    The total sum of rescue medication consumption will be recorded.

  3. SCORAD [ Time Frame: baseline and 36 week ]
    Change of SCORAD will be assessed.


Secondary Outcome Measures :
  1. DLQI [ Time Frame: baseline and 36 week ]
    Change of Dermatology Life Quality Index will be assessed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471119


Locations
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China, Zhejiang
Second Affiliated Hospital,School of Medicine,Zhejiang University.
Hangzhou, Zhejiang, China, 310009
Sponsors and Collaborators
Zhejiang University
Wolwo Bio-pharmaceutical Co. LTD.
Huashan Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Peking University Third Hospital
Tongji Hospital
First Affiliated Hospital of Suzhou Medical College
Investigators
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Principal Investigator: Min Zheng, Doctor Second Affiliated Hospital, School of Medicine, Zhejiang University
More Information
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Responsible Party: Min Zheng, Director of dermatology department,Professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT01471119    
Other Study ID Numbers: WOLWO-CT-A1.0
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2015
Keywords provided by Min Zheng, Zhejiang University:
sublingual immunotherapy
atopic dermatitis
Dermatophagoides Farinae Drops
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases