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

Astellas

Status and phase

Completed

Phase 4

Conditions

Dermatitis, Atopic

Treatments

Drug: pimecrolimus cream

Drug: tacrolimus ointment

Study type

Interventional

Funder types

Industry

Identifiers

20-02-006

Details and patient eligibility

About

A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic Dermatitis in pediatric patients

Enrollment

426 patients

Sex

All

Ages

2 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient has a diagnosis of Atopic Dermatitis rated mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area, and the maximum of 20% of the body 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