Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis

A Clinical Study Continued From the Confirmatory Study to Validate the Efficacy and Safety of Pimecrolimus Cream in Pediatric Atopic Dermatitis Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00231998

Enrollment

240

Registered

2005-10-04

Start date

2004-05-31

Completion date

2005-06-30

Last updated

2007-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, ASM981, pimecrolimus

Brief summary

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

Interventions

DRUGPimecrolimus

Pimecrolimus cream 1 %

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 16 Years

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

Design outcomes

Primary

Measure	Time frame
Safety assessed by adverse events (AEs)	—

Secondary

Measure	Time frame
Number of flares during 26 weeks of treatment	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026