Back to results

Sublingual Immunotherapy in Patients With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Dermatophagoides Farinae Drops Group 1

Dermatophagoides Farinae Drops Group 2

Dermatophagoides Farinae Drops Group 3

Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring sublingual immunotherapy, atopic dermatitis, Dermatophagoides Farinae Drops

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Second Affiliated Hospital,School of Medicine,Zhejiang University.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Dermatophagoides Farinae Drops Group 1

Dermatophagoides Farinae Drops Group 2

Dermatophagoides Farinae Drops Group 3

Placebo

Arm Description

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 2 is the group with maintenance dose of one drop of grade 5 Dermatophagoides Farinae and 2 drops of placebo.

Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae.

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

Outcomes

Primary Outcome Measures

average anesis interval

The average duration of last 3 whole anesis interval.

Rescue medication consumption

The total sum of rescue medication consumption will be recorded.

SCORAD

Change of SCORAD will be assessed.

Secondary Outcome Measures

DLQI

Change of Dermatology Life Quality Index will be assessed.

Full Information

NCT ID

NCT01471119

First Posted

November 9, 2011

Last Updated

August 16, 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

1. Study Identification

Unique Protocol Identification Number

NCT01471119

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

sublingual immunotherapy, atopic dermatitis, Dermatophagoides Farinae Drops

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

239 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dermatophagoides Farinae Drops Group 1

Arm Type

Experimental

Arm Description

Dermatophagoides Farinae Drops Group 1 is the group with maintenance dose of 2 drops of grade 5 Dermatophagoides Farinae and 1 drop of placebo.

Arm Title

Dermatophagoides Farinae Drops Group 2

Arm Type

Experimental

Arm Description

Dermatophagoides Farinae Drops Group 2 is the group with maintenance dose of one drop of grade 5 Dermatophagoides Farinae and 2 drops of placebo.

Arm Title

Dermatophagoides Farinae Drops Group 3

Arm Type

Experimental

Arm Description

Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae.

Arm Title

Placebo

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Dermatophagoides Farinae Drops Group 1

Intervention Description

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 Type

Biological

Intervention Name(s)

Dermatophagoides Farinae Drops Group 2

Intervention Description

Dermatophagoides Farinae Drops Group 2 is the group with maintenance dose of one drop of grade 5 Dermatophagoides Farinae and 2 drop of placebo.

Intervention Type

Biological

Intervention Name(s)

Dermatophagoides Farinae Drops Group 3

Intervention Description

Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

average anesis interval

Description

The average duration of last 3 whole anesis interval.

Time Frame

baseline and 36 week

Title

Rescue medication consumption

Description

The total sum of rescue medication consumption will be recorded.

Time Frame

36 week

Title

SCORAD

Description

Change of SCORAD will be assessed.

Time Frame

baseline and 36 week

Secondary Outcome Measure Information:

Title

DLQI

Description

Change of Dermatology Life Quality Index will be assessed.

Time Frame

baseline and 36 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Min Zheng, Doctor

Organizational Affiliation

Second Affiliated Hospital, School of Medicine, Zhejiang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Second Affiliated Hospital,School of Medicine,Zhejiang University.

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

12. IPD Sharing Statement

Learn more about this trial

Sublingual Immunotherapy in Patients With Atopic Dermatitis

We'll reach out to this number within 24 hrs