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Fexofenadine in Pruritic Skin Disease

Primary Purpose

Pruritus

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fexofenadine
Sponsored by
Handok Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional. Main criteria are listed hereafter: 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.

Sites / Locations

  • Handok

Outcomes

Primary Outcome Measures

The change of physician's assessment on pruritic score before and after 7-day treatment.

Secondary Outcome Measures

Patient visual analogue scale change and Overall satisfaction.

Full Information

First Posted
December 1, 2005
Last Updated
November 5, 2007
Sponsor
Handok Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00261079
Brief Title
Fexofenadine in Pruritic Skin Disease
Official Title
The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Handok Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
435 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fexofenadine
Primary Outcome Measure Information:
Title
The change of physician's assessment on pruritic score before and after 7-day treatment.
Secondary Outcome Measure Information:
Title
Patient visual analogue scale change and Overall satisfaction.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional. Main criteria are listed hereafter: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyou-Young Rhim, MD
Organizational Affiliation
Handok Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Handok
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Fexofenadine in Pruritic Skin Disease

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