Dermatitis, AtopicPhase 4NCT02534467
Does Treatment With Montelukast Improve Symptoms of Atopic Dermatitis in Children?
A Phase 4 study testing Montelukast in people with Dermatitis, Atopic, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial summary
An open-label (outcome assessor blinded) prospective crossover cohort study of children 6-16 years assessing effects of Montelukast on moderate to severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Montelukast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Jul 2015to 4 Dec 2018
- Phase
- Phase 4
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 6-16 years old with moderate to severe atopic dermatitis (SCORAD >25) despite topical therapy (corticosteroids and emollients) for at least 2 months Patients aged 6-16 years old with moderate to severe atopic dermatitis (SCORAD >25) despite immunosuppressive therapy (azathioprine, cyclosporine, methotrexate) for at least 2 months
Who cannot join
- Patients with mild atopic dermatitis (SCORAD <25) Patients who have received phototherapy in the past 8 weeks Patients with history of sensitivity to leukotriene receptor antagonists
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Montelukast as Adjunct Treatment in Children With Atopic Dermatitis
An open-label (outcome assessor blinded) prospective crossover cohort study of children 6-16 years assessing effects of Montelukast on moderate to severe atopic dermatitis.
Read the detailed description
An open-label, prospective cohort study with two arms over 16 weeks comprising 8 weeks of treatment with montelukast and 8 weeks without treatment of montelukast. All patients will be followed from recruitment to the study end date.
Study Population 62 patients aged 6-16 years old with moderate to severe atopic dermatitis recruited from the Royal Children's Hospital and Box Hill Hospital dermatology clinics having already previously received eczema education (SCORAD >25) Study Product Oral tablet montelukast Dose Regimen For patients 6-8 years old - 4mg montelukast once daily For patients 9-13 years old - 5mg montelukast once daily For patients 14-16 years old - 10mg montelukast once daily Evaluation Criteria Primary objective measurement: mean change in SCORAD index at 8 weeks Patients will be randomized into 2 arms: Arm 1 treated with montelukast therapy over 8 weeks followed by no montelukast therapy for 8 weeks. Arm 2 followed for 8 weeks without montelukast therapy followed by 8 weeks with montelukast therapy.
Assessment Schedule Clinical assessment will be conducted at baseline (week 0), and reviewed every 4 weeks over 16 weeks with a safety follow-up visit 2 weeks after the treatment ends (week 18). At the first clinic visit, demographic data, medical history and baseline SCORAD and cDLQI will be recorded. cDLQI will be completed by the participants. Participants with SCORAD <25 are considered to have mild disease and will not be included in the study. Suitable participants will be prescribed oral montelukast as an adjunct to their standard topical therapy (corticosteroids, emollients) or immunosuppressive therapy. Adverse effects, SCORAD (assessed by a blinded assessor) and cDLQI will be assessed at each review.
Data will be analyzed based on intention-to-treat. Paired data on SCORAD and cDLQI will be analyzed. A p value <0.05 will be considered statistically significant. A 30% improvement in SCORAD and cDLQI scores will be considered clinically significant.
- Conditions
- Dermatitis, Atopic
- Being tested
- Montelukast
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called Apo-Montelukast, Singulair
daily dose according to age for 8 weeks out of 16 weeks of assessment
| Study group | Role | What they receive |
|---|---|---|
| Montelukast-Standard | Experimental | 8 weeks of montelukast and standard therapy crossing over to 8 weeks of only standard therapy Receives: Drug: Montelukast |
| Standard-Montelukast | Active comparator | 8 weeks of standard therapy only crossing over to 8 weeks of montelukast and standard therapy Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale)
assessed by blinded assessor
Measured: at 8 weeks
Secondary outcomes (3)
Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale)
assessed by a blinded assessor
Measured: at 4 weeks
Change in children's Dermatology Life Quality Index cDLQI (Units on a scale)
Measured: at 8 weeks
Change in children's Dermatology Life Quality Index cDLQI (Units on a scale)
Measured: at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study start9 Jul 2015
- Primary completion4 Dec 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Sponsor
- Investigators
- John C Su, FRACP, FACD, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534467
- Sponsor's protocol ID
- 35095A
- Status last verified
- Aug 2019
- First submitted
- 13 Aug 2015
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montelukast as Adjunct Treatment in Children With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02534467
- Acronym / sponsor ID
- 35095A
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Monash University
- Study start
- 9 Jul 2015 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 27 Aug 2015 (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.
An open-label (outcome assessor blinded) prospective crossover cohort study of children 6-16 years assessing effects of Montelukast on moderate to severe atopic dermatitis.
Detailed description
An open-label, prospective cohort study with two arms over 16 weeks comprising 8 weeks of treatment with montelukast and 8 weeks without treatment of montelukast. All patients will be followed from recruitment to the study end date.
Study Population 62 patients aged 6-16 years old with moderate to severe atopic dermatitis recruited from the Royal Children's Hospital and Box Hill Hospital dermatology clinics having already previously received eczema education (SCORAD >25) Study Product Oral tablet montelukast Dose Regimen For patients 6-8 years old - 4mg montelukast once daily For patients 9-13 years old - 5mg montelukast once daily For patients 14-16 years old - 10mg montelukast once daily Evaluation Criteria Primary objective measurement: mean change in SCORAD index at 8 weeks Patients will be randomized into 2 arms: Arm 1 treated with montelukast therapy over 8 weeks followed by no montelukast therapy for 8 weeks. Arm 2 followed for 8 weeks without montelukast therapy followed by 8 weeks with montelukast therapy.
Assessment Schedule Clinical assessment will be conducted at baseline (week 0), and reviewed every 4 weeks over 16 weeks with a safety follow-up visit 2 weeks after the treatment ends (week 18). At the first clinic visit, demographic data, medical history and baseline SCORAD and cDLQI will be recorded. cDLQI will be completed by the participants. Participants with SCORAD <25 are considered to have mild disease and will not be included in the study. Suitable participants will be prescribed oral montelukast as an adjunct to their standard topical therapy (corticosteroids, emollients) or immunosuppressive therapy. Adverse effects, SCORAD (assessed by a blinded assessor) and cDLQI will be assessed at each review.
Data will be analyzed based on intention-to-treat. Paired data on SCORAD and cDLQI will be analyzed. A p value <0.05 will be considered statistically significant. A 30% improvement in SCORAD and cDLQI scores will be considered clinically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast-Standard | Experimental | Drug: Montelukast8 weeks of montelukast and standard therapy crossing over to 8 weeks of only standard therapy |
| Standard-Montelukast | Active comparator | Drug: Montelukast8 weeks of standard therapy only crossing over to 8 weeks of montelukast and standard therapy |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients aged 6-16 years old with moderate to severe atopic dermatitis (SCORAD >25) despite topical therapy (corticosteroids and emollients) for at least 2 months Patients aged 6-16 years old with moderate to severe atopic dermatitis (SCORAD >25) despite immunosuppressive therapy (azathioprine, cyclosporine, methotrexate) for at least 2 months
Key exclusion criteria (1 listed)
- Patients with mild atopic dermatitis (SCORAD <25) Patients who have received phototherapy in the past 8 weeks Patients with history of sensitivity to leukotriene receptor antagonists
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 |
|---|---|---|
| MontelukastAlso: Apo-Montelukast, Singulairdaily dose according to age for 8 weeks out of 16 weeks of assessment | Drug | Montelukast-Standard, Standard-Montelukast |
Primary outcome
Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale)
Time frame: at 8 weeks
assessed by blinded assessor
3 secondary outcomes
Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale)
Time frame: at 4 weeks
Change in children's Dermatology Life Quality Index cDLQI (Units on a scale)
Time frame: at 8 weeks
Change in children's Dermatology Life Quality Index cDLQI (Units on a scale)
Time frame: at 4 weeks
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 22 Aug 2019.
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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.
John C Su, FRACP, FACD principal investigator
Murdoch Childrens Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Montelukast in people with Dermatitis, Atopic, run by Murdoch Childrens Research Institute at 1 site in Australia.
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 1 inclusion and 1 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 22 Aug 2019. 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 Australia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale) (time frame: at 8 weeks). 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 22 Aug 2019.