Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis

• Status: Completed
• Trial end date: 2017-05-15
• Target enrollment: 0
• Participant gender: All

Summary

To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis.

To establish superiority of each active treatment over the placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mylan Inc.
• Collaborator: DPT Laboratories, Ltd.
• Treatments: Pimecrolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Non-immuno compromised male or female aged 8 years and older

• Clinical diagnosis of mild to moderate Atopic Dermatitis (AD)

• Failed to respond adequately to other topical prescription treatments for AD, or for whom those treatments are not advisable.

• A diagnosis of AD for at least 3 months

• An Investigator's Global Assessment (IGA) of disease severity of mild or moderate at baseline (score of 2 or 3)

• Affected area of AD involvement at least 5% body surface area (BSA)

• Treated with a bland emollient for at least 7 days

Exclusion Criteria:

• Females who are pregnant, breast feeding, or who wish to become pregnant during the study period

• Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected atopic dermatitis, impetigo).

• Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations

• History or presence of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, ichthyosis, or scabies.

• History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders

• Concurrent disease or treatment likely to interfere with the study treatment or evaluations

• Known allergy or hypersensitivity to pimecrolimus or any other component of the drug products

• Not willing to minimize or avoid natural and artificial sunlight exposure during treatment