Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis

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Novartis

Status and phase

Completed
Phase 4

Conditions

Atopic Dermatitis

Treatments

Drug: Pimecrolimus
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00130364
CASM981C2440

Details and patient eligibility

About

This study is not being conducted in the United States of America (USA). Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.

Sex

All

Ages

2 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Mild to moderate facial atopic dermatitis
  • Patients intolerant of, or dependent on, topical corticosteroids

Exclusion criteria

  • Concurrent skin diseases (infections)
  • Immunocompromised
  • Recently received phototherapy or systemic therapy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

200 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Pimecrolimus
Treatment:
Drug: Pimecrolimus
2
Placebo Comparator group
Description:
Pimecrolimus vehicle cream
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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