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...
Date First Received: December 1, 2005
Last Updated: November 5, 2007
Verified by: Handok Pharmaceuticals Co., Ltd., November 2007
Clinical Trial Phase: Phase 4 | Start Date: April 2005
Overall Status: Completed
Estimated Enrollment: 435
Brief Summary
Official Title: “The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Fexofenadine
Outcome Measures for this Clinical Trial
Primary Measures
- The change of physician's assessment on pruritic score before and after 7-day treatment.
Secondary Measures
- Patient visual analogue scale change and Overall satisfaction.
Criteria for Participation in this Clinical Trial
- 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.
- All patients diagnosed with atopic dermatitis, contact dermatitis
- 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.
Main criteria are listed hereafter:
Inclusion Criteria:
Exclusion Criteria:
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Handok Pharmaceuticals Co., Ltd.
Overall Clinical Trial Officials and Contacts
Hyou-Young Rhim, MD Study Director Handok Pharmaceuticals Co., Ltd.
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00261079
Study ID Number: M016455_4125
ClinicalTrials.gov Identifier: NCT00261079
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
