Fexofenadine in Pruritic Skin Disease

Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261079
• Other study ID #: M016455_4125
• Status: Completed
• Phase: Phase 4
• First received: December 1, 2005
• Last updated: November 5, 2007
• Start date: April 2005
• Est. completion date: October 2006

Study information

• Verified date: November 2007
• Source: Handok Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pruritus
• Skin Diseases

Intervention

Drug:
• Fexofenadine

Locations

Country	Name	City	State
Korea, Republic of	Handok	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Handok Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of physician's assessment on pruritic score before and after 7-day treatment.
Secondary	Patient visual analogue scale change and Overall satisfaction.