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

Mylan

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo Cream; Drug: Pimecrolimus Cream, 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03107611

CD-14-875

Details and patient eligibility

About

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.

Enrollment: 654 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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654 participants in 3 patient groups, including a placebo group

Test

Experimental group

Description:

Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days

Treatment:

Drug: Pimecrolimus Cream, 1%

Drug: Pimecrolimus Cream, 1%

Reference Standard

Active Comparator group

Description:

Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days

Treatment:

Drug: Pimecrolimus Cream, 1%

Drug: Pimecrolimus Cream, 1%

Placebo

Placebo Comparator group

Description:

Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days

Treatment:

Drug: Placebo Cream