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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509990
• Other study ID #: CASM981CVE01
• Status: Completed
• Phase: Phase 4
• First received: July 31, 2007
• Last updated: April 16, 2018
• Start date: April 2005

Study information

• Verified date: April 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Pimecrolimus
Pimecrolimus cream 1 %

Locations

Country	Name	City	State
Mexico	Novartis Investigative Site	Mexico
Mexico	Novartis Investigative Site	Monterrey
Mexico	Novartis Investigative Site	Puebla
Venezuela	Novartis Investigative Site	Aragua
Venezuela	Novartis Investigative Site, Edo	Carabobo
Venezuela	Novartis Investigative Site	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Mexico,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	• 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

External Links

•   Results for CASM981CVE01 from the Novartis Clinical Trials website