Completed

Evaluation of the Efficacy and Safety of Desloratadine Syrup in Childhood Atopic Dermatitis

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What is being tested

desloratadine

Drug
Who is being recruted

Dermatitis+8

+ Dermatitis, Atopic

+ Hypersensitivity

From 6 to 12 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 2003
See protocol details

Summary

Principal SponsorOrganon and Co
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2003

Actual date on which the first participant was enrolled.

The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius) syrup in children with allergic skin inflammation. Patients took desloratadine syrup once a day for 28 days. Once a week, the doctor measured the patient's symptoms. This measurement is called SCORAD. The doctor also rated how much relief the patient got from treatment and recorded any side effects.

Official TitleEvaluation of the Efficacy and Safety of Desloratadine Syrup in Childhood Atopic Dermatitis
NCT00817076
Principal SponsorOrganon and Co
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisDermatitis, AtopicHypersensitivityHypersensitivity, ImmediateImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin Diseases, GeneticSkin and Connective Tissue DiseasesSkin Diseases, EczematousGenetic Diseases, Inborn

Criteria

6 inclusion criteria required to participate
Children must be from >= 6 to < 12 years of age, of either sex and any race.
Children's parent(s) or legal representative(s) must demonstrate their willingness to participate in the study and comply with its procedures by signing an informed consent.
Children must be in general good health; i.e. they must be free of any clinically significant disease other than atopic dermatitis (AD) that would interfere with study evaluations.
Children's parent(s) or legal representative(s) must understand and be able to adhere to the dosing and visit schedule, and agree to report concomitant medications and adverse events to the Investigator or designee.
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5 exclusion criteria prevent from participating
Children who have not observed the designated washout period for any of the prohibited medications.
Children with bronchial asthma who require chronic use of inhaled or systemic corticosteroids.
Children with a history of hypersensitivity to desloratadine, or any of its excipients.
Children who have any current evidence of clinically significant hematopoietic, metabolic, cardiovascular, immunologic, neurologic, hematologic, gastrointestinal, hepatic, renal, psychiatric, or cerebrovascular, or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect children safety.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers