Fexofenadine in Pruritic Skin Disease

The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease

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

Study Overview

• Status: Completed
• Conditions: Pruritus
• Intervention / Treatment: Drug: Fexofenadine

• Study Type: Interventional
• Enrollment (Actual): 435
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Handok

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Patient visual analogue scale change and Overall satisfaction.

Collaborators and Investigators

• Sponsor: Handok Inc.
• Investigators: Study Director: Hyou-Young Rhim, MD, Handok Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion: December 7, 2022
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: December 1, 2005
• First Submitted That Met QC Criteria: December 1, 2005
• First Posted (Estimate): December 2, 2005

Study Record Updates

• Last Update Posted (Estimate): November 7, 2007
• Last Update Submitted That Met QC Criteria: November 5, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Pruritus; Skin Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Fexofenadine
• Other Study ID Numbers: M016455_4125

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No