Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Allergic Skin Inflammation (P03475)

Last updated: February 7, 2022
Sponsor: Organon and Co
Overall Status: Completed

Phase

3

Condition

Eczema (Atopic Dermatitis - Pediatric)

Rash

Allergy

Treatment

N/A

Clinical Study ID

NCT00817076
P03475
  • Ages 6-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 toparticipate in the study and comply with its procedures by signing an informedconsent.
  • Children must be in general good health; i.e. they must be free of any clinicallysignificant disease other than atopic dermatitis (AD) that would interfere with studyevaluations.
  • Children's parent(s) or legal representative(s) must understand and be able to adhereto the dosing and visit schedule, and agree to report concomitant medications andadverse 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 tomanifest 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 severitywill 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.

Exclusion

Exclusion Criteria:

  • Children who have not observed the designated washout period for any of the prohibitedmedications.
  • Children with bronchial asthma who require chronic use of inhaled or systemiccorticosteroids.
  • Children with a history of hypersensitivity to desloratadine, or any of itsexcipients.
  • 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 thejudgment of the Investigator, may interfere with the study evaluations or affectchildren safety.
  • A known lack or response to H1-antihistamines.

Study Design

Total Participants: 40
Study Start date:
March 01, 2003
Estimated Completion Date:
July 31, 2003