Back to resultsAssessment of Pruritus Improvement With Pimecrolimus Treatment on the Areas Affected by Mild-to-moderate AD, in Patients 2- to 11- Year-old
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Pimecrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, children, pimecrolimus, eczema
Eligibility 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.
Sites / Locations
- Novartis Investigative Site
Outcomes
Primary Outcome Measures
Change in pruritus Visual Analogic Scale (VAS) with respect to the basal score between and within treatment groups, daily evaluation.
Secondary Outcome Measures
• 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
Full Information
NCT ID
NCT00510003
First Posted
July 31, 2007
Last Updated
November 16, 2016
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00510003
Brief Title
Assessment of Pruritus Improvement With Pimecrolimus Treatment on the Areas Affected by Mild-to-moderate AD, in Patients 2- to 11- Year-old
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, children, pimecrolimus, eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus
Other Intervention Name(s)
Elidel
Intervention Description
Pimecrolimus cream 1 %
Primary Outcome Measure Information:
Title
Change in pruritus Visual Analogic Scale (VAS) with respect to the basal score between and within treatment groups, daily evaluation.
Secondary Outcome Measure Information:
Title
• 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis Pharma AG, Basel, Switzerland
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigative Site
City
Madrid
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
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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