Open Label Study of Long Term Treatment of Pediatric Treatment of Atopic Dermatitis With Pimecrolimus Cream 1% Within a Usual Clinical Setting

Open Label Multicenter Study, 52 Weeks Duration, Using Pimecrolimus Cream 1% for the Long-term Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Patients Within a Usual Clinical Setting

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00509990

Enrollment

200

Registered

2007-08-01

Start date

2005-04-30

Completion date

Unknown

Last updated

2018-04-18

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, pimecrolimus, children

Brief summary

An open-label, multicenter study, of long term management to evaluate effectiveness, tolerability and safety of pimecrolimus cream 1% in pediatric patients with mild to moderate atopic dermatitis in a daily practice

Interventions

DRUGPimecrolimus

Pimecrolimus cream 1 %

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Months to 12 Years

Healthy volunteers

Inclusion criteria

* Age ≥ 3 months to 12 years old * Clinical diagnosis of atopic dermatitis * History of mild to moderate atopic dermatitis * Investigator Global Assessment ≥ 1 (almost clear/clear of disease) * Written informed consent

Exclusion criteria

* Investigator Global Assessment ≥ 4 (severe/very severe disease) * Patients with active skin viral infections (i.e, herpes simplex, herpes zoster, varicella) * Patients with atopic dermatitis, with active clinical infection on area of disease. All active infections must be treated prior to trial inclusion * Patients in an Immunosuppressive state or with history of malignant disease * Patients with clinical conditions other that Atopic Dermatitis that according to the investigator may interfere with the evaluation (i.e, Psoriasis, Netherton Syndrome) * Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
To evaluate the effectiveness of pimecrolimus cream 1% in the long-term management in mild to moderate atopic dermatitis in pediatric patients in a daily practice, as assessed by: • Investigator Global Assessment • Facial Investigator Global Ass	—

Secondary

Measure	Time frame
• To monitor the safety of pimecrolimus cream 1% in the long-term management as assessed by Adverse Events and Serious Adverse Events collection • To evaluate quality of life of both parent and patient assessed by questionnaire. • To determine ste	—

Countries

Mexico, Venezuela

Outcome results

None listed

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