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

Atopic Dermatitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121316
• Other study ID #: CASM981C2442
• Status: Completed
• Phase: Phase 4
• First received: July 13, 2005
• Last updated: January 10, 2008
• Start date: October 2004
• Est. completion date: July 2005

Study information

• Verified date: January 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: Ministry of HealthSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Pimecrolimus
Pimecrolimus Cream 1 %
• Placebo
Vehicle cream (placebo cream)

Locations

Country	Name	City	State
Switzerland	This study is not being conducted in the United States	Novartis Pharma AG

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)
Secondary	Percentage of responders in overall Eczema Area and Severity Index (EASI) score
Secondary	Percentage of responders in the head and neck EASI score
Secondary	Percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score
Secondary	Percentage of patients achieving a score of 0 or 1 for the pruritus score (absent or mild)
Secondary	Effects on skin atrophy and telangiectasia (spider veins) existing at baseline