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

Primary Purpose

Atopic Eczema

Status

Completed

Phase

Phase 4

Locations

South Africa

Study Type

Interventional

Intervention

Pimecrolimus cream 1%

About this trial

This is an interventional treatment trial for Atopic Eczema focused on measuring Atopic eczema, Pimecrolimus, Children, Quality of life, Safety, Atopic dermatitis

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Investigative Sites

Outcomes

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.

Full Information

NCT ID

NCT00484003

First Posted

June 7, 2007

Last Updated

February 13, 2008

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00484003

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2008

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Eczema

Keywords

Atopic eczema, Pimecrolimus, Children, Quality of life, Safety, Atopic dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Pimecrolimus cream 1%

Other Intervention Name(s)

Elidel

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Investigative Sites

City

Various Cities

Country

South Africa

12. IPD Sharing Statement

Learn more about this trial

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

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