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

Novartis1 site in 1 countryDecember 2004

ConditionsAtopic Dermatitis

DrugsPimecrolimus Cream 1%

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Atopic Dermatitis
Sponsor: Novartis
Locations: 1
Primary Endpoint: Investigator Global Assessment (IGA) score for the whole body and for the face only.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2004

End Date

December 2005

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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.