A Quality of Life and Safety Study With Pimecrolimus Cream, 1% in Children (Age 2-12 Years) With Atopic Dermatitis

Official Title: “A 3-Month Open Label, National, Quality of Life , and Safety Study With Pimecrolimus Cream, 1% in Children (Age 2-12 Years ) With Atopic Dermatitis”

The study will evaluate the safety and effect of pimecrolimus cream 1% on quality of life of caregivers of South African children with mild to moderate atopic dermatitis (AD).

Intervention(s) in this Clinical Trial

• Drug: Pimecrolimus cream 1%

Primary Measures

• Quality of Life assessment on scheduled visits at Day 1 (Baseline), Day 14 and Day 90 or day of early discontinuation visit.

Secondary Measures

• Safety data will be collected by monitoring and recording all adverse events (AEs)and Serious Adverse Events(SAEs) throughout the duration of the trial.

Inclusion Criteria:

• Male or female
• Age ≥2 years ≤12 years of age
• Atopic dermatitis on sensitive skin areas only ( i.e. face , neck and flexures )
• Subjects in whom other treatment modalities are inadvisable according to the investigator's clinical opinion or have failed on other treatment modalities due to intolerance or inadequate response.
• Patients with a history of mild to moderate AD
• Subjects should present at visit 1 with a clear clinical diagnosis of mild to moderate AD.
• Subject's parents or legal guardian must have been informed of the study procedures and must have signed the Informed Consent form approved for the study prior to any study related procedures

Exclusion Criteria:

• Subjects who have active viral infections at the site(s) of treatment. In the presence of other dermatological infections, the use of appropriate antimicrobial agents should be instituted.
• Subjects who present with systemic malignancy or active lymphoproliferative diseases/disorders (e.g., lymphoma, neoplastic disease, chronic lymphoproliferation).
• Subjects who present with clinical conditions other than AD that can, in the opinion of the investigator, interfere with the evaluation
• Subjects who are receiving photo-therapy (e.g., PUVA, UVB) or immunosuppressive therapy (e.g., cyclosporine, FK-506 [tacrolimus]).
• Subjects who have used investigational drugs within 8 weeks prior to first application of study medication or intended use of other investigational drugs during the course of this study.
• Subjects who have used, or are using 0.03% or 0.1% tacrolimus ointment.
• Pimecrolimus cream 1% is contraindicated in subjects who have known or suspected hypersensitivity to pimecrolimus or any components of the cream
• Subjects not medically stable or subjects with any condition which, in the opinion of the investigator, should render the subject ineligible for the study.
• Pregnancy and lactation (if applicable)
• Pimecrolimus cream 1% should not be used during pregnancy or lactation
• Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00484003

Study ID Number: CASM981CZA01

ClinicalTrials.gov Identifier: NCT00484003

Health Authority: South Africa: Medicines Control Council