Sublingual Immunotherapy in Patients With Atopic Dermatitis

NCT01471119 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2018-08-17

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Wolwo Bio-pharmaceutical Co. LTD.

    collaborator UNKNOWN
  • Huashan Hospital

    collaborator OTHER
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER
  • Peking University Third Hospital

    collaborator OTHER
  • Tongji Hospital

    collaborator OTHER
  • First Affiliated Hospital of Suzhou Medical College

    collaborator OTHER
  • Zhejiang University

    lead OTHER

Principal Investigators

  • Min Zheng, Doctor · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01471119 on ClinicalTrials.gov