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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00121316
First received: July 13, 2005
Last updated: January 10, 2008
Last verified: January 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
 Drug: Pimecrolimus
Drug: Placebo
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: October 2004
Study Completion Date: July 2005
Arms Assigned Interventions
Experimental: 1
Pimecrolimus
 Drug: Pimecrolimus
Pimecrolimus Cream 1 %
Other Name: Elidel
Placebo Comparator: 2
Matching vehicle cream (placebo)
 Drug: Placebo
Vehicle cream (placebo cream)

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121316

Locations
Switzerland
This study is not being conducted in the United States
Novartis Pharma AG, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00121316     History of Changes
Other Study ID Numbers: CASM981C2442
Study First Received: July 13, 2005
Last Updated: January 10, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
Sweden: Medical Products Agency

Keywords provided by Novartis:
Atopic dermatitis
pimecrolimus

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013