Open Label Study of Long Term Treatment of Pediatric Treatment of Atopic Dermatitis With Pimecrolimus Cream 1% Within a Usual Clinical Setting
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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
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 Measures
• 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
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Ages Eligible for Study:
3 Months to 12 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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