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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Other trials in China

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 groups in NCT01471119
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.

Oct 2011Jun 2015

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
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RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Active, not recruiting
Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic Dermatitis
Not yet recruiting
Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis
Atopic Dermatitis, Psoriasis

All Atopic Dermatitis trials

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.

Detailed description

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.

Related trials for Atopic Dermatitis

RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Active, not recruiting
Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic Dermatitis
Not yet recruiting
Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis
Atopic Dermatitis, Psoriasis

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?

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?

On the ClinicalTrials.gov record for NCT01471119.

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.