Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00130364
First received: August 12, 2005
Last updated: January 10, 2008
Last verified: January 2008
  Purpose

This study is not being conducted in the United States of America (USA).

Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients 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: Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis

Resource links provided by NLM:


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 patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score
  • The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score
  • The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild)
  • Time to clearance of facial IGA (score of 0 or 1)

Estimated Enrollment: 200
Study Start Date: August 2005
Study Completion Date: August 2006
Arms Assigned Interventions
Experimental: 1
Pimecrolimus
Drug: Pimecrolimus
Pimecrolimus 1 % cream
Other Name: Elidel
Placebo Comparator: 2
Pimecrolimus vehicle cream
Drug: Placebo
Pimecrolimus vehicle cream (placebo)

  Eligibility

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Mild to moderate facial atopic dermatitis
  • Patients intolerant of, or dependent on, topical corticosteroids

Exclusion Criteria:

  • Concurrent skin diseases (infections)
  • Immunocompromised
  • Recently received phototherapy or systemic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130364

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

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00130364     History of Changes
Other Study ID Numbers: CASM981C2440
Study First Received: August 12, 2005
Last Updated: January 10, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
South Korea: Korea Food and Drug Administration (KFDA)
Slovakia: State Institute for Drug Control

Keywords provided by Novartis:
Atopic dermatitis
T-cell
pimecrolimus
children
facial
Facial atopic dermatitis

Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
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 September 16, 2014