The Effectiveness of Montelukast on Atopic Dermatitis in Koreans - Full Text View

Sponsored by:	Soonchunhyang University Hospital
Information provided by:	Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:	NCT00903357

Purpose

The purpose of this study is to assess the clinical effectiveness of Montelukast in children (2~6 years old) with atopic dermatitis and identify the pathophysiologic background of Montelukast on the role of modulating the atopic dermatitis measured by urinary Leukotriene 4 (LTE4) and Eosinophil protein X.

Condition	Intervention
Atopic Dermatitis	Drug: Placebo (ascorbic acid), following montelukast sodium Drug: Montelukast sodium, following placebo (ascorbic acid)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Efficacy Study
Official Title:	A Double Blind, Randomized, Crossover Study to Compare the Effectiveness of Montelukast on Atopic Dermatitis in Koreans

Resource links provided by NLM:

Drug Information available for: Ascorbic acid Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Soonchunhyang University Hospital:

Primary Outcome Measures:

Check SCORAD index for severity of atopic dermatitis, symptom diary, blood chemistry and Urinary LTE4 & EPX after drug administration [ Time Frame: 8 weeks after patient recruitment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Check SCORAD index for severity of atopic dermatitis, symptom diary, blood chemistry and Urinary LTE4 & EPX after 2-weeks wash-out period [ Time Frame: 8 weeks after wash-out period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	54
Study Start Date:	June 2009
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental Group A received active medication (montelukast 4 mg each day) for 8 weeks followed by a crossover to 8 weeks of placebo after 2-weeks washout period.	Drug: Montelukast sodium, following placebo (ascorbic acid) Patients in Group A will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks. And after 2 weeks wash-out period, they will receive chewable ascorbic acid placebo for 8 weeks.
Group B: Experimental Group B received placebo medication (ascorbic acid) for 8 weeks followed by a crossover to 8 weeks of active medication (montelukast 4 mg each day) after 2-weeks washout period.	Drug: Placebo (ascorbic acid), following montelukast sodium Patients in Group B will receive chewable ascorbic acid placebo for 8 weeks. And after 2 weeks wash-out period, they will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks.

Detailed Description:

Leukotriene B4 (LTB4) and the cysteinyl-leukotrienes LTC4, LTD4 and LTE4 are potent proinflammatory mediators derived from arachidonic acid through the 5- lipoxygenase pathway. They are secreted from eosinophils and other inflammatory cells such as mast cells and macrophages. The primary action of leukotrienes includes contraction of human airway muscle, chemotaxis, and increased vascular permeability, with secondary effects of inhibiting allergen-induced early and late responses. Several in vivo and in vitro studies suggest a role for cysteinyl leukotrienes in the pathogenesis of atopic dermatitis and there is a rationale for the use of pharmacological agents to antagonize their effects in the treatment of atopic dermatitis. Levels of LTE4 measured in urine (Urinary-LTE4) may be a useful measure of whole-body cysteinyl-leukotriene production in vivo, because that LTE4 is a stable urinary metabolite of LTC4 and LTD4. Urinary-LTE4 has been measured in individuals with atopic dermatitis, but in small-scale studies, and the results are conflicting.

Eligibility

Ages Eligible for Study:	2 Years to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The ages of 2 to 6 years old, 54 children with moderate to severe atopic dermatitis diagnosed by the criteria of Haniffin and Rajka were included in the study.
Volunteer children with moderate to severe atopic dermatitis were recruited from the Pediatric Allergy and respiratory Center of the SoonChunHyang University Hospital (Seoul, Korea). At the time of recruitment, written consent was obtained. The ethical committee at the SoonChunHyang University Hospital approved the trial.
Volunteers who agreed by their parents.
The severity of their disease was assessed by modified SCORAD index.

Exclusion Criteria:

Too severe atopic dermatitis defined as the sum of scores is 80 and above by SCORAD index.
A history of liver disease; allergy to montelukast or cross-reacting medication; use of phenobarbital, phenytoin or rifampicin.
Patients on systemic steroids, immune-suppression or Korean herbal medicine during the previous 6 weeks.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903357

Contacts

Contact: Bok Yang Pyun, M.D., PhD	+82-2-709-9340	bypyun@hosp.sch.ac.kr
Contact: Hyeon Jong Yang, M.D.	+82-2-709-9339	ilove902@hanmail.net

Locations

Korea, Republic of
Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital
Seoul, Korea, Republic of, 140-743

Sponsors and Collaborators

Soonchunhyang University Hospital

Investigators

Study Chair:

Bok Yang Pyun, M.D., PhD.

Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital

More Information

No publications provided

Responsible Party:	Pediatric Allergy & Respiratory Center, Soonchunhyang University Hospital ( Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital )
Study ID Numbers:	schallergy
Study First Received:	May 14, 2009
Last Updated:	May 14, 2009
ClinicalTrials.gov Identifier:	NCT00903357 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Soonchunhyang University Hospital:

Atopic dermatitis
Montelukast

Study placed in the following topic categories:

Dermatitis, Atopic
Antioxidants
Skin Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Trace Elements
Hormones
Leukotriene Antagonists
Vitamin C

Montelukast
Hypersensitivity
Genetic Diseases, Inborn
Vitamins
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Micronutrients
Skin Diseases, Genetic
Ascorbic Acid
Dermatitis

Additional relevant MeSH terms:

Respiratory System Agents
Antioxidants
Dermatitis, Atopic
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Hypersensitivity
Vitamins
Therapeutic Uses
Skin Diseases, Eczematous
Micronutrients

Skin Diseases, Genetic
Dermatitis
Immune System Diseases
Skin Diseases
Growth Substances
Anti-Asthmatic Agents
Protective Agents
Pharmacologic Actions
Montelukast
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Ascorbic Acid

ClinicalTrials.gov processed this record on September 10, 2009