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Completed

NCT Number: NCT00121381

Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis

Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pediatric Care Medical Group, Inc., Huntington Beach, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Severe atopic dermatitis
  • 5% of total body surface area (TBSA) affected

Exclusion criteria

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

Treatment and study plan

Pimecrolimus plus topical corticosteroid (TCS)

Drug

Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily

Other names: Elidel

Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)

Drug

twice daily administration

Primary outcomes

  1. Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)

Secondary outcomes

  1. Incidence of all other adverse events

  2. Time to relapse of atopic dermatitis

  3. Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity)

  4. Efficacy measured by IGA (treatment success and improvement)

  5. Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2005
Study completion
2007
First posted
Jul 21, 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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