NCT00261079

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
435

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

November 7, 2007

Status Verified

November 1, 2007

First QC Date

December 1, 2005

Last Update Submit

November 5, 2007

Conditions

Pruritus

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Patient visual analogue scale change and Overall satisfaction.

Interventions

FexofenadineDRUG

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients diagnosed with atopic dermatitis, contact dermatitis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Handok

Seoul, South Korea

Location

MeSH Terms

Conditions

Pruritus

Interventions

fexofenadine

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hyou-Young Rhim, MD

    Handok Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 1, 2005

First Posted

December 2, 2005

Study Start

April 1, 2005

Study Completion

October 1, 2006

Last Updated

November 7, 2007

Record last verified: 2007-11

Locations

KR(1)