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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00261079
Enrollment
435
Registered
2005-12-02
Start date
2005-04-30
Completion date
2006-10-31
Last updated
2007-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pruritus

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

Interventions

DRUGFexofenadine

Sponsors

Handok Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Patient visual analogue scale change and Overall satisfaction.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026