Fexofenadine in Pruritic Skin Disease

• Sponsor: Handok Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00261079
• Collaborator: (none)
• Enrollment: 435
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 24.2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pruritus	Drug: Fexofenadine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 435 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease
• Study Start Date: Apr 1, 2005
• Actual Study Completion Date: Oct 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Patient visual analogue scale change and Overall satisfaction. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Handok	Seoul		Korea, Republic of

Sponsors and Collaborators

• Handok Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00261079
• Other Study ID Numbers: M016455_4125
• First Posted: Dec 2, 2005
• Last Update Posted: Nov 7, 2007
• Last Verified: Nov 1, 2007

• Additional relevant MeSH terms: Pruritus; Skin Diseases; Fexofenadine

Study Results

No Results Posted as of Nov 7, 2007