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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150059

Enrollment

Unknown

Registered

2005-09-08

Start date

2004-12-31

Completion date

2005-12-31

Last updated

2008-02-15

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, eczema, mild to moderate, children, IGA

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.

Interventions

DRUGPimecrolimus Cream 1%

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Months to No maximum

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Philippines

Outcome results

None listed

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