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

Condition(s) targeted: Atopic Dermatitis

Intervention: Pimecrolimus (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis Pharma AG Basel, Switzerland

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

Official title: 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

Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: 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 outcome: • 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

Minimum age: 3 Months. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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/exclusion criteria may apply

Novartis Investigative Site, Puebla, Mexico

Novartis Investigative Site, Monterrey, Mexico

Novartis Investigative Site, Mexico, Mexico

Novartis Investigative Site, Aragua, Venezuela

Novartis Investigative Site, Caracas, Venezuela

Novartis Investigative Site, Edo, Carabobo, Venezuela

Starting date: April 2005
Ending date: September 2007
Last updated: February 13, 2008