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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:
ClinicalTrials.gov Identifier:
NCT00484003
First Posted: June 8, 2007
Last Update Posted: February 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
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).

Condition Intervention Phase
Atopic Eczema Drug: Pimecrolimus cream 1% Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome 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.

Study Start Date: October 2004
Study Completion Date: December 2004
Intervention Details:
    Drug: Pimecrolimus cream 1%
    Other Name: Elidel
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484003


Locations
South Africa
Investigative Sites
Various Cities, South Africa
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00484003     History of Changes
Other Study ID Numbers: CASM981CZA01
First Submitted: June 7, 2007
First Posted: June 8, 2007
Last Update Posted: February 15, 2008
Last Verified: February 2008

Keywords provided by Novartis:
Atopic eczema
Pimecrolimus
Children
Quality of life
Safety
Atopic dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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