## Protocol Section
### Identification Module
**NCT ID:** NCT00261079

**Brief Title:** Fexofenadine in Pruritic Skin Disease

**Official Title:** The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease

#### Organization Study ID Info
**ID:** M016455_4125
#### Organization
**Class:** INDUSTRY
**Full Name:** Handok Inc.
### Status Module
#### Completion Date
**Date:** 2006-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2007-11-07

**Type:** ESTIMATED

**Last Update Submit Date:** 2007-11-05

**Overall Status:** COMPLETED

#### Start Date
**Date:** 2005-04

**Status Verified Date:** 2007-11

#### Study First Post Date
**Date:** 2005-12-02
**Type:** ESTIMATED
**Study First Submit Date:** 2005-12-01
**Study First Submit QC Date:** 2005-12-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Handok Inc.

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Pruritus

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 435

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Fexofenadine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

#### Secondary Outcomes

**Measure:** Patient visual analogue scale change and Overall satisfaction.

### Eligibility Module

**Eligibility 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.

**Maximum Age:** 70 Years

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Handok

#### Overall Officials

**Official 1:**

**Affiliation:** Handok Inc.

**Name:** Hyou-Young Rhim, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012877

- Term: Skin Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M15674

- Name: Skin Diseases

- Relevance: HIGH

- As Found: Skin Diseases

- ID: M14396

- Name: Pruritus

- Relevance: HIGH

- As Found: Pruritus

- ID: M15680

- Name: Skin Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011537

- Term: Pruritus

- ID: D000012871

- Term: Skin Diseases

### Intervention Browse Module - Ancestors

- ID: D000018926

- Term: Anti-Allergic Agents

- ID: D000039563

- Term: Histamine H1 Antagonists, Non-Sedating

- ID: D000006634

- Term: Histamine H1 Antagonists

- ID: D000006633

- Term: Histamine Antagonists

- ID: D000018494

- Term: Histamine Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: AAll

- Name: Anti-Allergic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M252074

- Name: Fexofenadine

- Relevance: HIGH

- As Found: Allogeneic Stem Cell Transplantation

- ID: M20962

- Name: Anti-Allergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9710

- Name: Histamine H1 Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M9708

- Name: Histamine

- Relevance: LOW

- As Found: Unknown

- ID: M212144

- Name: Histamine phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M24826

- Name: Histamine H1 Antagonists, Non-Sedating

- Relevance: LOW

- As Found: Unknown

- ID: M9709

- Name: Histamine Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000093230

- Term: Fexofenadine

### Misc Info Module

- Version Holder: 2024-05-24
