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

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.

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

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.

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