ClinicalTrials.Veeva

Menu

Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis

Novartis logo

Novartis

Status and phase

Completed
Phase 3

Conditions

Atopic Dermatitis

Treatments

Drug: Pimecrolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00231998
CASM981C1302

Details and patient eligibility

About

Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of Pimecrolimus cream will be evaluated in Japanese pediatric patients with atopic dermatitis. This study is a 6-month extension study following core study.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

Sex

All

Ages

2 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

    • Patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator
  • Patients whose guardians have given written informed consent to participation in this study

Exclusion criteria

    • Patients who failed in treatment compliance in the core study
  • Patients who had a major violation of the protocol in the core study

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

240 participants in 1 patient group

1
Experimental group
Treatment:
Drug: Pimecrolimus

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems