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Completed

NCT Number: NCT01471119

Sublingual Immunotherapy in Patients With Atopic Dermatitis

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Second Affiliated Hospital,School of Medicine,Zhejiang University.

Hangzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dermatophagoides Farinae Drops Group 1

Biological

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

Biological

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

Dermatophagoides Farinae Drops Group 3

Biological

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

Placebo

Biological

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

Primary outcomes

  1. average anesis interval

    Time frame: baseline and 36 week

    The average duration of last 3 whole anesis interval.

  2. Rescue medication consumption

    Time frame: 36 week

    The total sum of rescue medication consumption will be recorded.

  3. SCORAD

    Time frame: baseline and 36 week

    Change of SCORAD will be assessed.

Secondary outcomes

  1. DLQI

    Time frame: baseline and 36 week

    Change of Dermatology Life Quality Index will be assessed.

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Collaborators

  • First Affiliated Hospital of Suzhou Medical College
  • Huashan Hospital
  • Peking University Third Hospital
  • Tongji Hospital
  • Wolwo Bio-pharmaceutical Co. LTD.
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Registry information

Official study title

Usefulness and Safety of Sublingual Dermatophagoides Farinae Drops in Patients With Atopic Dermatitis:A Randomized,Double-blind,Placebo-controlled Study.

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 11, 2011
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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