Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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To assess the safety of long-term use of cetirizine dry syrup in children with various type of cutaneous disease accompanied on pruritus.

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Detailed Description

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Conditions

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Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cetirizine Dry Syrup

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronic urticaria
* Eczema \& dermatitis group
* Atopic dermatitis
* Prurigo group: Acute prurigo, Prurigo subacuta, Chronic prurigo
* Pruritus cutaneous: Systemic pruritus cutaneous, Topical pruritus cutaneous
* Giving informed consent
* Children who have 2 grades or more pruritus score when assessed by the investigator or sub-investigator with the criteria for the diurnal or nocturnal pruritus score in the patient diary.
* Children with a pruritus severity of "2.Mild" or severer on the first day of the treatment period.

Exclusion Criteria

* have a history of drug hypersensitivity
* are pregnant, lactating or possibly pregnant female children.
* have asthma that requires the treatment with corticosteroid.
* cannot avoid the use of external steroid classified into "strong", "strongest" or "very strong".
* have pruritus only on face and head.
* have inappropriate complication of dermal disorder that may influence on the evaluation of the study drug.
* are undergoing specific desensitization therapy or immunomodulation therapy or phototherapy.

Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No