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Trial record 17 of 154 for:    Dermatitis, Atopic, 8

Does Treatment With Montelukast Improve Symptoms of Atopic Dermatitis in Children?

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ClinicalTrials.gov Identifier: NCT02534467
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Monash University
Information provided by (Responsible Party):
Murdoch Childrens Research Institute

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: Montelukast Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Montelukast as Adjunct Treatment in Children With Atopic Dermatitis
Actual Study Start Date : July 9, 2015
Actual Primary Completion Date : December 4, 2018
Actual Study Completion Date : December 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Montelukast

Arm Intervention/treatment
Experimental: Montelukast-Standard
8 weeks of montelukast and standard therapy crossing over to 8 weeks of only standard therapy
Drug: Montelukast
daily dose according to age for 8 weeks out of 16 weeks of assessment
Other Name: Apo-Montelukast, Singulair

Active Comparator: Standard-Montelukast
8 weeks of standard therapy only crossing over to 8 weeks of montelukast and standard therapy
Drug: Montelukast
daily dose according to age for 8 weeks out of 16 weeks of assessment
Other Name: Apo-Montelukast, Singulair




Primary Outcome Measures :
  1. Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale) [ Time Frame: at 8 weeks ]
    assessed by blinded assessor


Secondary Outcome Measures :
  1. Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale) [ Time Frame: at 4 weeks ]
    assessed by a blinded assessor

  2. Change in children's Dermatology Life Quality Index cDLQI (Units on a scale) [ Time Frame: at 8 weeks ]
  3. Change in children's Dermatology Life Quality Index cDLQI (Units on a scale) [ Time Frame: at 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534467


Locations
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Australia, Victoria
The Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Sponsors and Collaborators
Murdoch Childrens Research Institute
Monash University
Investigators
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Principal Investigator: John C Su, FRACP, FACD Murdoch Children's Research Institute

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Responsible Party: Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT02534467     History of Changes
Other Study ID Numbers: 35095A
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action