Efficacy and Safety of Pimecrolimus Cream 1% in Patients ≥ 3 Months of Age With Mild or Moderate Atopic Dermatitis

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00150059

Purpose

To evaluate the efficacy and safety of pimecrolimus cream 1% in its registered indication (treatment of patients > 3 months of age with mild to moderate atopic dermatitis)

This study is not enrolling patients in the United States.

Condition	Intervention	Phase
Atopic Dermatitis	Drug: Pimecrolimus Cream 1%	Phase IV

Drug Information available for: Pimecrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Novartis:

Primary Outcome Measures:

Investigator Global Assessment (IGA) score for the whole body and for the face only.
Pruritus (itch) severity assessments, and patient's self-assessment of disease control at the start of study and on day 7, 30 and 90 after treatment initiation.
Safety assessed by adverse events.

Study Start Date:	December 2004
Study Completion Date:	December 2005

Eligibility

Ages Eligible for Study:	3 Months and older
Genders Eligible for Study:	Both

Criteria

The patient population must consist of male or female outpatients, age ≥3 months old with mild to moderate atopic dermatitis (IGA ≥ 1). Exclusion criteria are pregnancy, having active viral infections at the site(s) of treatment, presenting with systemic malignancy or active lymphoproliferative diseases/disorders, receiving phototherapy or immunosuppressive therapy, having used tacrolimus ointment and known allergy or hypersensitivity.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150059

Locations

Philippines
This study is not being conducted in the United States
Investigative Site, Philippines

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Healthcare Philippines

Novartis Pharmaceuticals

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CASM981CPH01
Study First Received:	September 7, 2005
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00150059
Health Authority:	Philippines: Bureau of Food and Drugs

Keywords provided by Novartis:

atopic dermatitis, eczema, mild to moderate, children, IGA

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate
Skin Diseases, Eczematous

Pimecrolimus
Tacrolimus
Eczema
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009