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

NCT00121316 | Completed Phase 4

• 1 other identifier: CASM981C2442
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; pimecrolimus

Outcome Measures

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 (5)

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

• Percentage of responders in the head and neck EASI score

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

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

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

Study Arms (2)

1

EXPERIMENTAL

Pimecrolimus

Drug: Pimecrolimus

2

PLACEBO COMPARATOR

Matching vehicle cream (placebo)

Drug: Placebo

Interventions

Pimecrolimus DRUG

Pimecrolimus Cream 1 %

Also known as: Elidel

1

Placebo DRUG

Vehicle cream (placebo cream)

2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

This study is not being conducted in the United States

Novartis Pharma AG, Switzerland

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

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

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 13, 2005
• First Posted: July 21, 2005
• Study Start: October 1, 2004
• Study Completion: July 1, 2005
• Last Updated: January 15, 2008

Record last verified: 2008-01

Locations

CH (1)