The Effectiveness of Montelukast on Atopic Dermatitis in Koreans

Status Completed

Clinical Trial Summary

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(EDN).

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00903357
Study type	Interventional
Source	Soonchunhyang University Hospital
Contact
Status	Completed
Phase	N/A
Start date	August 2009
Completion date	April 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05018806` - Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis	Phase 2
Completed	`NCT04090229` - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis	Phase 1
Terminated	`NCT03847389` - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis	Phase 1/Phase 2
Active, not recruiting	`NCT05388760` - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)	Phase 2
Completed	`NCT05530707` - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer	N/A
Completed	`NCT02595073` - Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis	Phase 3
Recruiting	`NCT05509023` - Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)	Phase 2
Recruiting	`NCT05048056` - Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis	Phase 2
Completed	`NCT04598269` - Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis	Phase 2
Recruiting	`NCT03936335` - An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Withdrawn	`NCT03089476` - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy	N/A
Recruiting	`NCT05029895` - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated	`NCT03654755` - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis	Phase 2
Completed	`NCT04556461` - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function	Phase 2
Recruiting	`NCT04818138` - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort	N/A
Completed	`NCT03719742` - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer	N/A
Completed	`NCT05375955` - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.	Phase 2
Completed	`NCT03441568` - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control	N/A
Recruiting	`NCT06366932` - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models	Phase 4
Completed	`NCT03304470` - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis	Phase 2