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

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

NCT00484003•Novartis

View on ClinicalTrials.gov

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

Age

2 - 12 years

Sex

ALL

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

Locations (1)

Investigative Sites

Various Cities, South Africa

Key Dates

Start Date

October 1, 2004

Completion Date

December 1, 2004

Last Updated

February 15, 2008

Conditions

Atopic Eczema

Interventions

Pimecrolimus cream 1%

DRUG

A Study to Evaluate the Emollient Performance of Doublebase Once in the Treatment of Atopic Eczema

NCT06453512

Atopic Eczema

View study

RECRUITING

TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry: Dutch National Registry for Patients With Moderate-to-severe Atopic Eczema on Photo- or Systemic Therapies

NCT03621137

Moderate-to-severe Atopic Eczema

View study

NOT_YET_RECRUITINGPHASE4

Efficacy of Crisaborole 2% Cream Versus Placebo in Mild to Moderate Atopic Eczema

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Emollient Performance of Doublebase Once in the Treatment of Atopic Eczema

TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry: Dutch National Registry for Patients With Moderate-to-severe Atopic Eczema on Photo- or Systemic Therapies

Efficacy of Crisaborole 2% Cream Versus Placebo in Mild to Moderate Atopic Eczema

Cutaneous Biomarkers in Atopic Eczema Using a Non-Invasive Micro-Suction Device in Babies

A Community-based Assessment of Skin Care, Allergies, and Eczema

A Study to Evaluate Adex Gel in the Treatment of Atopic Eczema.