NCT00817076

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

January 5, 2009

Last Update Submit

February 7, 2022

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

  • Demonstration of the efficacy of desloratadine in relieving the total symptoms of atopic dermatitis through SCORAD Index

    Baseline, Day 8, Day 15, and Day 29

Secondary Outcomes (2)

  • The percent of subjects who rate their response to desloratadine as either Complete, Marked, or Moderate Relief

    Day 8, Day 15, and Day 29

  • Evaluate the number of adverse events during therapy

    Day 8, Day 15, and Day 29

Study Arms (1)

1

EXPERIMENTAL
Drug: desloratadine

Interventions

desloratadineDRUG

desloratadine syrup; 5.0 mL once daily for 28 days

Also known as: Clarinex; Aerius; SCH 34117; descarboethoxyloratadine
1

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • The diagnosis of AD will be performed according the Hanifin and Rajka criteria (Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Derm Venereol (Stockhr) 92 (suppl): 44-70, 1980): to be included in this study, children needed to manifest at least 3 major features and 3 minor features at visit 1 (day 1).
  • Children must be clinically symptomatic with AD at visit 1 (day 1). Disease severity will be estimated using the SCORAD Index (European task force on atopic dermatitis. Severity scoring of atopic dermatitis: the SCORAD Index. Dermatology 186: 23-31, 1993), and child must have a SCORAD Index at least \>= 35.

You may not qualify if:

  • 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.
  • A known lack or response to H1-antihistamines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

desloratadine

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2009

First Posted

January 6, 2009

Study Start

March 1, 2003

Primary Completion

July 1, 2003

Study Completion

July 1, 2003

Last Updated

February 16, 2022

Record last verified: 2022-02