Fexofenadine in Pruritic Skin Disease
Information source: Handok Pharmaceuticals Co., Ltd.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pruritus
Intervention: Fexofenadine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Handok Pharmaceuticals Co., Ltd. Official(s) and/or principal investigator(s):
Hyou-Young Rhim, MD, Study Director, Affiliation: Handok Pharmaceuticals Co., Ltd.
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
Clinical Details
Official title: The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The change of physician's assessment on pruritic score before and after 7-day treatment.
Secondary outcome: Patient visual analogue scale change and Overall satisfaction.
Eligibility
Minimum age: 12 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Handok, Seoul, Korea, Republic of
Additional Information
Starting date: April 2005
Ending date: October 2006
Last updated: November 5, 2007
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