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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00509990

Collaborator

(none)

200

Enrollment

Locations

33.3

Patients Per Site

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Pimecrolimus	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 12 Years

Sexes Eligible for Study:

All

Accepts 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/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	Country
1	Novartis Investigative Site	Mexico	Mexico
2	Novartis Investigative Site	Monterrey	Mexico
3	Novartis Investigative Site	Puebla	Mexico
4	Novartis Investigative Site	Aragua	Venezuela
5	Novartis Investigative Site, Edo	Carabobo	Venezuela
6	Novartis Investigative Site	Caracas	Venezuela