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

NCT00484003 | Completed Phase 4

• 1 other identifier: CASM981CZA01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Atopic Eczema

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Pimecrolimus cream 1% DRUG

Also known as: Elidel

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Investigative Sites

Various Cities, South Africa

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 7, 2007
• First Posted: June 8, 2007
• Study Start: October 1, 2004
• Study Completion: December 1, 2004
• Last Updated: February 15, 2008

Record last verified: 2008-02

Locations

ZA (1)