Atopic DermatitisPhase 2NCT01471119
Sublingual Immunotherapy in Patients With Atopic Dermatitis
A Phase 2 study testing Dermatophagoides Farinae Drops Group 1, Dermatophagoides Farinae Drops Group 2 and Dermatophagoides Farinae Drops Group 3 in people with Atopic Dermatitis, run by Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Dermatophagoides Farinae Drops Group 1, Dermatophagoides Farinae Drops Group 2 and Dermatophagoides Farinae Drops Group 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital,School of Medicine,Zhejiang University.
Hangzhou, Zhejiang, 310009
About this study
Official title: Usefulness and Safety of Sublingual Dermatophagoides Farinae Drops in Patients With Atopic Dermatitis:A Randomized,Double-blind,Placebo-controlled Study.
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Dermatophagoides Farinae Drops Group 1, Dermatophagoides Farinae Drops Group 2, Dermatophagoides Farinae Drops Group 3, Placebo
- Keywords
- sublingual immunotherapy, atopic dermatitis, Dermatophagoides Farinae Drops
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermatophagoides Farinae Drops Group 1Biological
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 2Biological
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 3Biological
Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae.
PlaceboBiological
Placebo Group is the group with maintenance dose of 3 drops of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Dermatophagoides Farinae Drops Group 1 | Experimental | Dermatophagoides Farinae Drops Group 1 is the group with maintenance dose of 2 drops of grade 5 Dermatophagoides Farinae and 1 drop of placebo. Receives: Biological: Dermatophagoides Farinae Drops Group 1 |
| Dermatophagoides Farinae Drops Group 2 | Experimental | Dermatophagoides Farinae Drops Group 2 is the group with maintenance dose of one drop of grade 5 Dermatophagoides Farinae and 2 drops of placebo. Receives: Biological: Dermatophagoides Farinae Drops Group 2 |
| Dermatophagoides Farinae Drops Group 3 | Experimental | Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae. Receives: Biological: Dermatophagoides Farinae Drops Group 3 |
| Placebo | Experimental | Placebo Group is the group with maintenance dose of 3 drops of placebo. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
average anesis interval
The average duration of last 3 whole anesis interval.
Measured: baseline and 36 week
Rescue medication consumption
The total sum of rescue medication consumption will be recorded.
Measured: 36 week
SCORAD
Change of SCORAD will be assessed.
Measured: baseline and 36 week
Secondary outcomes (1)
DLQI
Change of Dermatology Life Quality Index will be assessed.
Measured: baseline and 36 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Min Zheng, Zhejiang University
- Investigators
- Min Zheng, Doctor, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471119
- Sponsor's protocol ID
- WOLWO-CT-A1.0
- Status last verified
- Aug 2015
- First submitted
- 9 Nov 2011
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness and Safety of Sublingual Dermatophagoides Farinae Drops in Patients With Atopic Dermatitis:A Randomized,Double-blind,Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT01471119
- Acronym / sponsor ID
- WOLWO-CT-A1.0
- Conditions
- Atopic Dermatitis
- Keywords
- sublingual immunotherapy, atopic dermatitis, Dermatophagoides Farinae Drops
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- 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
- Study start
- Oct 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dermatophagoides Farinae Drops Group 1 | Experimental | Biological: Dermatophagoides Farinae Drops Group 1Dermatophagoides 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 | Experimental | Biological: Dermatophagoides Farinae Drops Group 2Dermatophagoides 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 | Experimental | Biological: Dermatophagoides Farinae Drops Group 3Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae. |
| Placebo | Experimental | Biological: PlaceboPlacebo Group is the group with maintenance dose of 3 drops of placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermatophagoides Farinae Drops Group 1Dermatophagoides 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 2Dermatophagoides 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 2 |
| Dermatophagoides Farinae Drops Group 3Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae. | Biological | Dermatophagoides Farinae Drops Group 3 |
| PlaceboPlacebo Group is the group with maintenance dose of 3 drops of placebo. | Biological | Placebo |
Primary outcome
average anesis interval
Time frame: baseline and 36 week
The average duration of last 3 whole anesis interval.
Rescue medication consumption
Time frame: 36 week
The total sum of rescue medication consumption will be recorded.
SCORAD
Time frame: baseline and 36 week
Change of SCORAD will be assessed.
1 secondary outcome
DLQI
Time frame: baseline and 36 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Zheng, Doctor principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dermatophagoides Farinae Drops Group 1, Dermatophagoides Farinae Drops Group 2 and Dermatophagoides Farinae Drops Group 3 in people with Atopic Dermatitis, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average anesis interval (time frame: baseline and 36 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.