- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00509990
Open Label Study of Long Term Treatment of Pediatric Treatment of Atopic Dermatitis With Pimecrolimus Cream 1% Within a Usual Clinical Setting
April 16, 2018 updated by: Novartis Pharmaceuticals
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
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
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mexico, Mexico
- Novartis Investigative Site
-
Monterrey, Mexico
- Novartis Investigative Site
-
Puebla, Mexico
- Novartis Investigative Site
-
-
-
-
-
Aragua, Venezuela
- Novartis Investigative Site
-
Carabobo, Venezuela
- Novartis Investigative Site, Edo
-
Caracas, Venezuela
- Novartis Investigative Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
• 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Novartis, Novartis Pharma AG, Basel, Switzerland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
July 31, 2007
First Submitted That Met QC Criteria
July 31, 2007
First Posted (Estimate)
August 1, 2007
Study Record Updates
Last Update Posted (Actual)
April 18, 2018
Last Update Submitted That Met QC Criteria
April 16, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Hypersensitivity
- Skin Diseases, Eczematous
- Dermatitis
- Eczema
- Dermatitis, Atopic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Calcineurin Inhibitors
- Pimecrolimus
Other Study ID Numbers
- CASM981CVE01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atopic Dermatitis
-
Catalysis SLCompletedAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related Conditions | Atopic Dermatitis \(AD\)Serbia
-
Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
-
ShaperonNot yet recruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of Scalp
-
University of California, San FranciscoSanofi; Regeneron PharmaceuticalsRecruitingEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related ConditionsUnited States
-
PfizerActive, not recruitingEczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, UnspecifiedUnited States, Canada, Czechia, Poland
-
AmgenCompletedDermatitis, Atopic DermatitisCanada, United States, Japan
-
Hadassah Medical OrganizationUnknownATOPIC DERMATITIS
-
SanofiCompletedAtopic Dermatitis | Dermatitis AtopicChina
-
SanofiCompletedDermatitis AtopicSaudi Arabia, Kuwait, United Arab Emirates
-
National Institute of Allergy and Infectious Diseases...Atopic Dermatitis Research NetworkCompletedAtopic Dermatitis (AD) | Non-atopic Healthy ControlsUnited States
Clinical Trials on Pimecrolimus
-
Actavis Inc.CompletedAtopic DermatitisUnited States
-
Glenmark Pharmaceuticals Ltd. IndiaCompletedAtopic DermatitisUnited States
-
Children's Hospital of PhiladelphiaNovartis PharmaceuticalsCompleted
-
Mylan Inc.DPT Laboratories, Ltd.CompletedAtopic DermatitisUnited States, Dominican Republic, Honduras
-
Par Pharmaceutical, Inc.Completed
-
NovartisCompletedDermatitis, AtopicUnited States
-
GlaxoSmithKlineWithdrawnLymphoma, Follicular | Lymphoma, Non-Hodgkin | Lymphoma, Small Cleaved-Cell, Follicular | Lymphoma, Large-Cell, FollicularUnited States
-
University of LeipzigNovartisWithdrawnLupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidGermany
-
University Hospital, GhentNovartisCompletedVitiligo VulgarisBelgium
-
Mylan Inc.Medicine Meda Pharmaceutical Information Consultancy (Beijing) Co., Ltd.Completed