A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With 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

NCT00666302

20-02-004

Details and patient eligibility

About

A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis

Enrollment: 413 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Atopic Dermatitis rated at least mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area
• Negative pregnancy test and agrees to practice effective birth control during the study

Exclusion criteria

• Skin disorder other than Atopic Dermatitis in the areas to be treated
• Extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
• Clinically infected Atopic Dermatitis at baseline
• Likely to require systemic corticosteroids; or likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
• Known hypersensitivity to macrolides or any excipient of either study medication
• Chronic condition which is either not stable or not well controlled
• Pregnant or breast feeding an infant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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413 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: tacrolimus ointment

2

Active Comparator group

Treatment:

Drug: pimecrolimus cream