Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Treating Pediatric Patients With Atopic Dermatitis

Astellas

Status and phase

Completed

Phase 4

Conditions

Dermatitis, Atopic

Treatments

Drug: tacrolimus ointment

Drug: pimecrolimus cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT00666159

20-02-005

Details and patient eligibility

About

Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in pediatric patients with Atopic Dermatitis

Full description

This is a two arm, randomized, investigator blinded study to compare Protopic Ointment to Elidel Cream in treating pediatric patients with moderate to severe Atopic Dermatitis

Enrollment

226 patients

Sex

All

Ages

2 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of Atopic Dermatitis which is rated moderate, severe or very severe using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body's surface area
If female, and of childbearing potential, patient has a negative pregnancy test and agrees to practice effective birth control during the study

Exclusion criteria

Patient has a skin disorder other than Atopic Dermatitis in the areas to be treated
Patient has extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
Patient has clinically infected Atopic Dermatitis at baseline
Patient is likely to require systemic corticosteroids, or the patient is likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
Patient has a known hypersensitivity to macrolides or any excipient of either study medication
Patient has a chronic condition which is either not stable or not well controlled
Patient is pregnant or breast feeding an infant