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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02534467




Registration number
NCT02534467
Ethics application status
Date submitted
13/08/2015
Date registered
27/08/2015
Date last updated
22/08/2019

Titles & IDs
Public title
Does Treatment With Montelukast Improve Symptoms of Atopic Dermatitis in Children?
Scientific title
Montelukast as Adjunct Treatment in Children With Atopic Dermatitis
Secondary ID [1] 0 0
35095A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermatitis, Atopic 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Montelukast

Experimental: Montelukast-Standard - 8 weeks of montelukast and standard therapy crossing over to 8 weeks of only standard therapy

Active Comparator: Standard-Montelukast - 8 weeks of standard therapy only crossing over to 8 weeks of montelukast and standard therapy


Treatment: Drugs: Montelukast
daily dose according to age for 8 weeks out of 16 weeks of assessment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale)
Timepoint [1] 0 0
at 8 weeks
Secondary outcome [1] 0 0
Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale)
Timepoint [1] 0 0
at 4 weeks
Secondary outcome [2] 0 0
Change in children's Dermatology Life Quality Index cDLQI (Units on a scale)
Timepoint [2] 0 0
at 8 weeks
Secondary outcome [3] 0 0
Change in children's Dermatology Life Quality Index cDLQI (Units on a scale)
Timepoint [3] 0 0
at 4 weeks

Eligibility
Key inclusion criteria
- 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
Minimum age
6 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/12/2018
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02534467
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John C Su, FRACP, FACD
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02534467