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Fexofenadine in Pruritic Skin Disease

H

Handok

Status and phase

Completed
Phase 4

Conditions

Pruritus

Treatments

Drug: Fexofenadine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00261079
M016455_4125

Details and patient eligibility

About

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

Enrollment

435 patients

Sex

All

Ages

12 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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