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

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:

MedlinePlus related topics: Eczema Itching

Drug Information available for: Pimecrolimus

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 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

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

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
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 23, 2013