Sublingual Immunotherapy in Patients With Atopic Dermatitis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atopic Dermatitis |
Biological: Dermatophagoides Farinae Drops Group 1 Biological: Dermatophagoides Farinae Drops Group 2 Biological: Dermatophagoides Farinae Drops Group 3 Biological: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Usefulness and Safety of Sublingual Dermatophagoides Farinae Drops in Patients With Atopic Dermatitis:A Randomized,Double-blind,Placebo-controlled Study. |
- average anesis interval [ Time Frame: baseline and 36 week ] [ Designated as safety issue: No ]The average duration of last 3 whole anesis interval.
- Rescue medication consumption [ Time Frame: 36 week ] [ Designated as safety issue: No ]The total sum of rescue medication consumption will be recorded.
- SCORAD [ Time Frame: baseline and 36 week ] [ Designated as safety issue: Yes ]Change of SCORAD will be assessed.
- DLQI [ Time Frame: baseline and 36 week ] [ Designated as safety issue: No ]Change of Dermatology Life Quality Index will be assessed.
| Estimated Enrollment: | 240 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
|
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.
|
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.
|
|
Experimental: Placebo
Placebo Group is the group with maintenance dose of 3 drops of placebo.
|
Biological: Placebo
Placebo Group is the group with maintenance dose of 3 drops of placebo.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Lunfei Liu, Dr | 86-571-87783743 | liulunfei@medmail.com.cn |
| Contact: Jisu Chen, Dr | 86-571-87783743 | cgmcjs@msn.com |
| China, Zhejiang | |
| Second Affiliated Hospital,School of Medicine,Zhejiang University. | Recruiting |
| Hangzhou, Zhejiang, China, 310009 | |
| Contact: Lunfei Liu, Dr 86-571-87783743 liulunfei@medmail.com.cn | |
| Contact: Jisu Chen, Dr 86-571-87783743 cgmcjs@msn.com | |
| Sub-Investigator: Lunfei Liu, Dr | |
| Sub-Investigator: Jisu Chen, Dr | |
| Sub-Investigator: Jianliang Yan, Dr | |
| Sub-Investigator: Jianyou Wang, Dr | |
| Principal Investigator: | Min Zheng, Doctor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
More Information
No publications provided
| Responsible Party: | Min Zheng, Director of dermatology department,Professor, Zhejiang University |
| ClinicalTrials.gov Identifier: | NCT01471119 History of Changes |
| Other Study ID Numbers: | WOLWO-CT-A1.0 |
| Study First Received: | November 9, 2011 |
| Last Updated: | December 17, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Zhejiang University:
|
sublingual immunotherapy atopic dermatitis Dermatophagoides Farinae Drops |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013