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Premary clinical efficacy and safety evaluation of sublingual immunotherapy in atopic dermatitis using "Dermatophagoides Farnae Dropes"

Premary clinical efficacy and safety evaluation of sublingual immunotherapy in atopic dermatitis using "Dermatophagoides Farnae Dropes"—a multi-centre, randomized, double-blind, placebo-controlled stu

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001694
Enrollment
Unknown
Registered
2011-11-07
Start date
2011-11-10
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Interventions

A:5#2 drops
B:5#1 drops
C:4#3 drops

Sponsors

Second Affiliated Hospital ZheJiang University College of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Adults of both sexes, age between 18an 60 years with actual AD; (2) Patients with a objective SCORAD value between 10 and 40; (3) According to histamine equivalent, the result of the skin prick test kit for Dermatophagoides Farinae should be positive, ++ or above; (4) Patients are able to understand and sign the informed consent form, and should get it before all the assessments; (5) The pregnancy texts of child-bearing period patients should be negetive, reliably contraception during the trial; (6) Compliant this clinical research plan.

Exclusion criteria

Exclusion criteria: (1) Patients who are allergic to non-dust-mite allergens, including wormwood pollen, plane tree pollen, the German cockroach, cat's fur/cat's epithelium, dog's fur/ dog's epithelium, Penicillium, milk, peanuts, Egg yellow, Egg white and at the same time, in the pricking test, the positive results of the above allergens must be stronger than dust-mite allergen with +++ or more; (2) Women in conception and lactation period or have conception project in one year; (3) Patients who had dermalosis may disturb the result assessment; (4) Patients treated with antihistamine or exteral drug in the 1 weeks before the start of the study; (5) Patients treated systemically with corticosteroids or immunosuppressant agents or leukotriene antagonist in the 4 weeks before the start of the study; (6) Patients treated with UV radiation in the 4 weeks before the start of the study; (7) Patients who had immunosuppressive diseases(example:malignant tumor of history of it, history of HIV), autoimmune diseases or history of pulmonary tuberculosis; (8) Patients subsequently severe liver disease(ALT and(or) 1.5 times above the upper limit of normal value), decreased renal function(serum creatinine above the upper limit of normal value) or any other severe diseases; (9) Patients with allergic bronchial asthma requiring systemic steroids and/or ß-receptor agonists(including injection, oral and inhalation); (10) Patients with beta-receptor blockers; (11) Patients who had a history of drup trials within the last 3 months; (12) Patients who had a history of immunotherapy with HDM with the last 3 years; (13) Patients with severe nental disorders; (14) Any other unsuited affairs to participate in clinical study.

Design outcomes

Primary

MeasureTime frame
indication medication scores;the changes in SCORAD versus baseline: including its decline value and decline percentage;

Secondary

MeasureTime frame
DLQI;the changes of skin lesions scope, and the rescue percentage of each clinical symptom;the changes of the level of itching and its effect on sleep;

Countries

China

Contacts

Public ContactZhang Lu
zhanglu@wolwobiotech.com+86 13651662647

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026