Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects

Novartis1 site in 1 countrySeptember 2004

ConditionsAtopic Dermatitis

InterventionsPimecrolimus

DrugsPimecrolimus

Overview

Phase: Phase 4
Intervention: Pimecrolimus
Conditions: Atopic Dermatitis
Sponsor: Novartis
Locations: 1
Primary Endpoint: Time to relapse of atopic dermatitis (defined as the exacerbation of atopic dermatitis to the level where a topical corticosteroid or alternative therapy is required).
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is not being conducted in the United States.

To investigate the relative efficacy of pimecrolimus cream 1% applied twice daily (b.i.d.) versus once daily (o.d.) in preventing the progression to disease "relapse".

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

September 2005

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Screening/Run-In period
•subjects who applied topical therapy (e.g. tar, topical corticosteroids) within 2 weeks prior to Screening
•subjects who received phototherapy (e.g. UVB, PUVA, Narrow Band) within 4 weeks of Screening
•subjects who received any systemic immunosuppressant
•subjects who received systemic steroids
•females who are pregnant or breast-feeding, or planning to become pregnant during the study
•subjects who are immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome) or have a history of malignancy (includes basal cell carcinoma, squamous cell carcinoma, melanoma)
•subjects with open skin infections (bacterial, viral or fungal) if at the application site.
•subjects will HSV (common cold sores) are allowed to participate in the study (if not at the application site).
•subjects who have head lice or scabies

Arms & Interventions

1

Pimecrolimus b.i.d.

Intervention: Pimecrolimus

2

Pimecrolimus o.d. and placebo o.d.

Intervention: Pimecrolimus

Outcomes

Primary Outcomes

Time to relapse of atopic dermatitis (defined as the exacerbation of atopic dermatitis to the level where a topical corticosteroid or alternative therapy is required).

Investigators Global Assessment (IGA) and pruritus (itch) assessment of atopic dermatitis at time of suspected relapse