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

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: Montelukast

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • The Royal Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Apo-Montelukast, Singulair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale)	assessed by blinded assessor	at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale)	assessed by a blinded assessor	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

Collaborators and Investigators

• Sponsor: Murdoch Childrens Research Institute
• Collaborators: Monash University
• Investigators: Principal Investigator: John C Su, FRACP, FACD, Murdoch Children's Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2015
• Primary Completion (Actual): December 4, 2018
• Study Completion (Actual): December 4, 2018

Study Registration Dates

• First Submitted: August 13, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 27, 2015

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: 35095A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No