Sublingual Immunotherapy in Patients With Atopic Dermatitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Zhejiang University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Wolwo Bio-pharmaceutical Co. LTD.
Fudan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
The third Hospital of Peking University,Beijing,China
Tongji Hospital
First affiliated Hospital,Suzhou University,Suzhou,China
Information provided by (Responsible Party):
Min Zheng, Zhejiang University
ClinicalTrials.gov Identifier:
NCT01471119
First received: November 9, 2011
Last updated: December 17, 2011
Last verified: December 2011
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Further study details as provided by Zhejiang University:

Primary Outcome Measures:
  • average anesis interval [ Time Frame: baseline and 36 week ] [ Designated as safety issue: No ]
    The average duration of last 3 whole anesis interval.

  • Rescue medication consumption [ Time Frame: 36 week ] [ Designated as safety issue: No ]
    The total sum of rescue medication consumption will be recorded.

  • SCORAD [ Time Frame: baseline and 36 week ] [ Designated as safety issue: Yes ]
    Change of SCORAD will be assessed.


Secondary Outcome Measures:
  • DLQI [ Time Frame: baseline and 36 week ] [ Designated as safety issue: No ]
    Change of Dermatology Life Quality Index will be assessed.


Estimated Enrollment: 240
Study Start Date: October 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471119

Contacts
Contact: Lunfei Liu, Dr 86-571-87783743 liulunfei@medmail.com.cn
Contact: Jisu Chen, Dr 86-571-87783743 cgmcjs@msn.com

Locations
China, Zhejiang
Second Affiliated Hospital,School of Medicine,Zhejiang University. Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Lunfei Liu, Dr    86-571-87783743    liulunfei@medmail.com.cn   
Contact: Jisu Chen, Dr    86-571-87783743    cgmcjs@msn.com   
Sub-Investigator: Lunfei Liu, Dr         
Sub-Investigator: Jisu Chen, Dr         
Sub-Investigator: Jianliang Yan, Dr         
Sub-Investigator: Jianyou Wang, Dr         
Sponsors and Collaborators
Zhejiang University
Wolwo Bio-pharmaceutical Co. LTD.
Fudan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
The third Hospital of Peking University,Beijing,China
Tongji Hospital
First affiliated Hospital,Suzhou University,Suzhou,China
Investigators
Principal Investigator: Min Zheng, Doctor Second Affiliated Hospital, School of Medicine, Zhejiang University
  More Information

No publications provided

Responsible Party: Min Zheng, Director of dermatology department,Professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT01471119     History of Changes
Other Study ID Numbers: WOLWO-CT-A1.0
Study First Received: November 9, 2011
Last Updated: December 17, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Zhejiang University:
sublingual immunotherapy
atopic dermatitis
Dermatophagoides Farinae Drops

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014