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OpenTrials
Completed

NCT Number: NCT00130364

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Disease Attributes Facies Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

This study is not being conducted in the United States

Novartis Pharmaceuticals, New Jersey, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pimecrolimus

Drug

Pimecrolimus 1 % cream

Other names: Elidel

Placebo

Drug

Pimecrolimus vehicle cream (placebo)

Primary outcomes

  1. The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)

Secondary outcomes

  1. Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score

  2. The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score

  3. The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild)

  4. Time to clearance of facial IGA (score of 0 or 1)

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2005
Study completion
2006
First posted
Aug 15, 2005
Registry last updated
Jan 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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