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Completed

NCT Number: NCT00121316

Safety and Efficacy of Pimecrolimus Cream 1% in Mild to Moderate Head and Neck Atopic Dermatitis (AD) Patients

This study is not being conducted in the United States.

Patients who are intolerant of topical corticosteroids (TCS) have either experienced an adverse event resulting from the use of TCS, or require unacceptable levels of exposure to TCS in order to control their AD. This is of particular concern for patients with recurrent flares on delicate skin areas such as the head and neck.

The purpose of this study is to investigate whether pimecrolimus cream 1%, a non-steroidal anti-inflammatory drug, is efficacious in treating mild to moderate head and neck AD in patients who are 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 Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

This study is not being conducted in the United States

Novartis Pharma AG, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 12 years of age or older
  • Mild to moderate facial AD at screening (facial IGA 2 - 3)
  • Patients intolerant of, or dependent on, topical corticosteroids
  • Diagnosis of atopic dermatitis by the Hanifin and Rajka criteria
  • For female patients, a negative pregnancy test. Women who are pregnant or who are breast-feeding may not be included in the study. Women of child-bearing potential must follow a medically recognized form of contraception.

Exclusion criteria

At baseline and throughout the study, patients:

  • Who have AD on greater than 30% of total body surface area in addition to facial eczema
  • Who have concurrent skin disease (e.g. acne) in the study area or active skin infections (active bacterial, viral or fungal infections or infestations, herpes simplex, herpes zoster, chicken pox), or other conditions that may interfere with the evaluation (e.g. generalized erythroderma, Netherton's syndrome)
  • Who are immunocompromised (e.g. Lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease (with the exception of treated basal-cell carcinoma)
  • Who have previously reported poor, no clinical response, or hypersensitivity to topical pimecrolimus cream (Elidel)
  • Who have received phototherapy (e.g. UVA, UVB) or systemic therapy (e.g.immunosuppressants, corticosteroids, cytostatics) known or suspected to have an effect on AD within 4 weeks of Visit 2
  • Who have received investigational drugs within 8 weeks of first application of study drug or planned use of other investigational drugs during participation of this study
  • Who are unlikely to comply with therapy

Treatment and study plan

pimecrolimus

Drug

Pimecrolimus Cream 1 %

Other names: Elidel

Placebo

Drug

Vehicle cream (placebo cream)

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 responders in overall Eczema Area and Severity Index (EASI) score

  2. Percentage of responders in the head and neck EASI score

  3. Percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score

  4. Percentage of patients achieving a score of 0 or 1 for the pruritus score (absent or mild)

  5. Effects on skin atrophy and telangiectasia (spider veins) existing at baseline

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Safety and Efficacy of Pimecrolimus Cream 1% in Mild to Moderate Head and Neck Atopic Dermatitis (AD) of Patients Intolerant to, or Dependant on, Topical Corticosteroids

Important dates

Study start
2004
Study completion
2005
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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