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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00484003
First received: June 7, 2007
Last updated: February 13, 2008
Last verified: February 2008

June 7, 2007
February 13, 2008
October 2004
Not Provided
Quality of Life assessment on scheduled visits at Day 1 (Baseline), Day 14 and Day 90 or day of early discontinuation visit.
Same as current
Complete list of historical versions of study NCT00484003 on ClinicalTrials.gov Archive Site
Safety data will be collected by monitoring and recording all adverse events (AEs)and Serious Adverse Events(SAEs) throughout the duration of the trial.
Same as current
Not Provided
Not Provided
 
A Quality of Life and Safety Study With Pimecrolimus Cream, 1% in Children (Age 2-12 Years) With Atopic Dermatitis
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).

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atopic Eczema
Drug: Pimecrolimus cream 1%
Other Name: Elidel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
December 2004
Not Provided

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

Both
2 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00484003
CASM981CZA01
Not Provided
External Affairs, Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP