Fexofenadine in Pruritic Skin Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00261079
Recruitment Status : Completed
First Posted : December 2, 2005
Last Update Posted : November 7, 2007
Information provided by:
Handok Pharmaceuticals Co., Ltd.

December 1, 2005
December 2, 2005
November 7, 2007
April 2005
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The change of physician's assessment on pruritic score before and after 7-day treatment.
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Complete list of historical versions of study NCT00261079 on Archive Site
Patient visual analogue scale change and Overall satisfaction.
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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
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Fexofenadine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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October 2006
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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.
Sexes Eligible for Study: All
12 Years to 70 Years   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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Handok Pharmaceuticals Co., Ltd.
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Study Director: Hyou-Young Rhim, MD Handok Pharmaceuticals Co., Ltd.
Handok Pharmaceuticals Co., Ltd.
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP