Clinical trial NCT00484003: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Eczema
Keywords: Atopic eczema
Pimecrolimus
Children
Quality of life
Safety
Atopic dermatitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-06-08
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Quality of Life assessment on scheduled visits at Day 1 (Baseline), Day 14 and Day 90 or day of early discontinuation visit.
Secondary outcomes:
measure: Safety data will be collected by monitoring and recording all adverse events (AEs)and Serious Adverse Events(SAEs) throughout the duration of the trial.
Other outcomes:
Locations:
city: Various Cities
country: South Africa
facility: Investigative Sites
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: