Sublingual Immunotherapy in Patients With Atopic Dermatitis

• ClinicalTrials.gov Identifier: NCT01471119
• Recruitment Status: Completed
• First Posted: November 11, 2011
• Last Update Posted: August 17, 2018
• Sponsor: Zhejiang University
• 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

Tracking Information

• First Submitted Date: November 9, 2011
• First Posted Date: November 11, 2011
• Last Update Posted Date: August 17, 2018
• Study Start Date: October 2011
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 17, 2011)

• average anesis interval [ Time Frame: baseline and 36 week ]
  The average duration of last 3 whole anesis interval.
• Rescue medication consumption [ Time Frame: 36 week ]
  The total sum of rescue medication consumption will be recorded.
• SCORAD [ Time Frame: baseline and 36 week ]
  Change of SCORAD will be assessed.

Original Primary Outcome Measures (submitted: November 9, 2011)

• average anesis interval [ Time Frame: 36 week ]
  The average lasting time of 3 whole anesis interval.
• Rescue medication consumption [ Time Frame: 36 week ]
  The total sum of rescue medication consumption will be recorded.
• SCORAD [ Time Frame: 36 week ]
  Change of SCORAD will be assessed.

Current Secondary Outcome Measures (submitted: December 17, 2011)

DLQI [ Time Frame: baseline and 36 week ]

Change of Dermatology Life Quality Index will be assessed.

Original Secondary Outcome Measures (submitted: November 9, 2011)

DLQI [ Time Frame: 36 week ]

Dermatology Life Quality Index will be assessed.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sublingual Immunotherapy in Patients With Atopic Dermatitis
• Official Title: Usefulness and Safety of Sublingual Dermatophagoides Farinae Drops in Patients With Atopic Dermatitis:A Randomized,Double-blind,Placebo-controlled Study.
• 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.
• 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
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Atopic Dermatitis

Intervention

• 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.
• 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.
• 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.
• Biological: Placebo
  Placebo Group is the group with maintenance dose of 3 drops of placebo.

Study Arms

• 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.
  Intervention: Biological: Dermatophagoides Farinae Drops Group 1
• 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.
  Intervention: Biological: Dermatophagoides Farinae Drops Group 2
• 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.
  Intervention: Biological: Dermatophagoides Farinae Drops Group 3
• Experimental: Placebo
  Placebo Group is the group with maintenance dose of 3 drops of placebo.
  Intervention: Biological: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 16, 2018): 239
• Original Estimated Enrollment (submitted: November 9, 2011): 240
• Actual Study Completion Date: June 2015
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01471119
• Other Study ID Numbers: WOLWO-CT-A1.0
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Min Zheng, Zhejiang University
• Original Responsible Party: Same as current
• Current Study Sponsor: Zhejiang University
• Original Study Sponsor: Same as current

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

Investigators

• Principal Investigator: Min Zheng, Doctor; Second Affiliated Hospital, School of Medicine, Zhejiang University

• PRS Account: Zhejiang University
• Verification Date: August 2015