Does Treatment With Montelukast Improve Symptoms of Atopic Dermatitis in Children?
Montelukast as Adjunct Treatment in Children With Atopic Dermatitis
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2015
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2015
CompletedFirst Submitted
Initial submission to the registry
August 13, 2015
CompletedFirst Posted
Study publicly available on registry
August 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2018
CompletedAugust 22, 2019
August 1, 2019
3.4 years
August 13, 2015
August 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale)
assessed by blinded assessor
at 8 weeks
Secondary Outcomes (3)
Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale)
at 4 weeks
Change in children's Dermatology Life Quality Index cDLQI (Units on a scale)
at 8 weeks
Change in children's Dermatology Life Quality Index cDLQI (Units on a scale)
at 4 weeks
Study Arms (2)
Montelukast-Standard
EXPERIMENTAL8 weeks of montelukast and standard therapy crossing over to 8 weeks of only standard therapy
Standard-Montelukast
ACTIVE COMPARATOR8 weeks of standard therapy only crossing over to 8 weeks of montelukast and standard therapy
Interventions
daily dose according to age for 8 weeks out of 16 weeks of assessment
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Murdoch Childrens Research Institutelead
- Monash Universitycollaborator
Study Sites (1)
The Royal Children's Hospital
Parkville, Victoria, 3052, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John C Su, FRACP, FACD
Murdoch Childrens Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2015
First Posted
August 27, 2015
Study Start
July 9, 2015
Primary Completion
December 4, 2018
Study Completion
December 4, 2018
Last Updated
August 22, 2019
Record last verified: 2019-08