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

Phase 4

Completed

• Conditions: Atopic Dermatitis

• Registration Number: NCT00509990
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2007-07-31
• Study First Submitted QC: 2007-07-31
• Study First Posted: 2007-08-01
• Primary Completion: 2007-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
• 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

Trial Locations

Locations (2)

Novartis Investigative Site; 🇻🇪 Caracas, Venezuela

Novartis Investigative Site, Edo; 🇻🇪 Carabobo, Venezuela