Fexofenadine in Pruritic Skin Disease

This study has been completed.

First Received: December 1, 2005 Last Updated: November 5, 2007 History of Changes

Sponsored by:	Handok Pharmaceuticals Co., Ltd.
Information provided by:	Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00261079

Purpose

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	Intervention	Phase
Pruritus	Drug: Fexofenadine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease

Resource links provided by NLM:

MedlinePlus related topics: Itching Skin Conditions

Drug Information available for: Fexofenadine Fexofenadine hydrochloride

U.S. FDA Resources

Further study details as provided by Handok Pharmaceuticals Co., Ltd.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Patient visual analogue scale change and Overall satisfaction.

Enrollment:	435
Study Start Date:	April 2005
Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	12 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261079

Locations

Korea, Republic of
Handok
Seoul, Korea, Republic of

Sponsors and Collaborators

Handok Pharmaceuticals Co., Ltd.

Investigators

Study Director:

Hyou-Young Rhim, MD

Handok Pharmaceuticals Co., Ltd.

More Information

No publications provided

Study ID Numbers:	M016455_4125
Study First Received:	December 1, 2005
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00261079 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Pruritus
Neurotransmitter Agents
Histamine Antagonists
Skin Diseases
Fexofenadine

Histamine phosphate
Histamine H1 Antagonists
Anti-Allergic Agents
Histamine

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine Antagonists
Skin Diseases
Therapeutic Uses
Physiological Effects of Drugs

Fexofenadine
Histamine Agents
Histamine H1 Antagonists
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009