Fexofenadine in Pruritic Skin Disease

NCT ID: NCT00261079

Last Updated: 2007-11-07

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

PHASE4

Total Enrollment

435 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-10-31

Brief Summary

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Primary objective:

* To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease

Secondary objective:

* To evaluate patient's satisfaction of Allegra treatment

Detailed Description

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Conditions

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Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Fexofenadine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients diagnosed with atopic dermatitis, contact dermatitis

Exclusion Criteria

* Other skin disease except atopic dermatitis, contact dermatitis.
* Subjects taken steroid within 4 weeks and antihistamine within 1 week before screening day.
* Pruritus localized only head and face
* Subjects with severe hepatic, renal, heart dysfunction.
* Subjects with history of alcohol and drug abuse.
* Pregnant and lactating women.
Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Handok Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Hyou-Young Rhim, MD

Role: STUDY_DIRECTOR

Handok Inc.

Locations

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Handok

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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M016455_4125

Identifier Type: -

Identifier Source: org_study_id