Back to resultsOpen Label Study of Long Term Treatment of Pediatric Treatment of Atopic Dermatitis With Pimecrolimus Cream 1% Within a Usual Clinical Setting
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Pimecrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, pimecrolimus, children
Eligibility 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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site, Edo
- Novartis Investigative Site
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00509990
Brief Title
Open Label Study of Long Term Treatment of Pediatric Treatment of Atopic Dermatitis With Pimecrolimus Cream 1% Within a Usual Clinical Setting
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 Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, pimecrolimus, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus
Other Intervention Name(s)
Elidel
Intervention Description
Pimecrolimus cream 1 %
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
• 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis Pharma AG, Basel, Switzerland
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigative Site
City
Mexico
Country
Mexico
Facility Name
Novartis Investigative Site
City
Monterrey
Country
Mexico
Facility Name
Novartis Investigative Site
City
Puebla
Country
Mexico
Facility Name
Novartis Investigative Site
City
Aragua
Country
Venezuela
Facility Name
Novartis Investigative Site, Edo
City
Carabobo
Country
Venezuela
Facility Name
Novartis Investigative Site
City
Caracas
Country
Venezuela
12. IPD Sharing Statement
Learn more about this trial
Open Label Study of Long Term Treatment of Pediatric Treatment of Atopic Dermatitis With Pimecrolimus Cream 1% Within a Usual Clinical Setting
We'll reach out to this number within 24 hrs