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Assessment of Pruritus Improvement With Pimecrolimus Treatment on the Areas Affected by Mild-to-moderate AD, in Patients 2- to 11- Year-old

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ClinicalTrials.gov Identifier: NCT00510003
Recruitment Status : Completed
First Posted : August 1, 2007
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is to assess the efficacy and safety of pimecrolimus cream 1% in relation to the improvement of pruritus in pediatric patients (2- to 11- year-old) with mild to moderate atopic dermatitis.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Pimecrolimus Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, 3-week, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Evaluate the Efficacy and Safety of Pimecrolimus Cream 1% in Pediatric Patients With Mild to Moderate Atopic Dermatitis
Study Start Date : December 2004
Actual Primary Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching
U.S. FDA Resources


Intervention Details:
    Drug: Pimecrolimus
    Pimecrolimus cream 1 %
    Other Name: Elidel


Primary Outcome Measures :
  1. Change in pruritus Visual Analogic Scale (VAS) with respect to the basal score between and within treatment groups, daily evaluation.

Secondary Outcome Measures :
  1. • Reduction ≥ 50% in pruritus VAS with respect to basal score (responding patients) between groups and within groups (daily evaluation). • Change in sleep quality VAS in the pimecrolimus group with respect to the basal score (daily evaluation), and


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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Male or female.
  • Age: between 2 - 12 years.
  • Outpatients with diagnosis of atopic dermatitis
  • Atopic dermatitis affecting ≥ 5% of Total Body Surface Area at Baseline Investigator's Global Assessment score of 2 (mild) or 3 (moderate).
  • Baseline visit pruritus (itching) severity assessment score of 2 (moderate) or 3 (severe).
  • Patients or patient's legal guardian who has been informed of the study procedures and has signed the informed consent form approved for the study prior to starting any study related procedures, including washout (in case that it would be necessary).

Exclusion Criteria:

  • Patients being breast-fed by women receiving systemic or prohibited medication.
  • Children with known hypersensitivity to study medication.
  • Children who received phototherapy or systemic therapy (immunosuppressants, cytostatics) known to affect atopic dermatitis within the previous month or topical therapy (tar, topical corticosteroids), systemic corticosteroids, systemic antibiotics or leukotriene antagonists within the previous week.
  • Children who received investigational drugs within 8 weeks prior to first application of study medication.
  • Children who had concurrent skin disease or active bacterial, viral or fungal infection.
  • Immunocompromised children (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or children with a history of malignant disease.

Other protocol-defined inclusion/exclusion criteria may apply.


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): NCT00510003


Locations
Spain
Novartis Investigative Site
Madrid, Spain
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Chair: Novartis Novartis Pharma AG Basel, Switzerland

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00510003     History of Changes
Other Study ID Numbers: CASM981CES02
First Posted: August 1, 2007    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Atopic dermatitis, children, pimecrolimus, eczema

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