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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Prospective, Multicenter, Double Blind, Parallel Assignment, Placebo Controlled Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® (Pimecrolimus) Cream, 1% in Patients With Mild to Moderate Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Pimecrolimus Cream, 1%
* Drug: Placebo Cream
* Drug: Pimecrolimus Cream, 1%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days | Drug: Pimecrolimus Cream, 1%<br> <br> |
| Active Comparator: Reference Standard<br>Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days | Drug: Pimecrolimus Cream, 1%<br> <br> * Other names: Elidel (pimecrolimus) Cream, 1%;|
| Placebo Comparator: Placebo<br>Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days | Drug: Placebo Cream<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) | Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting | Day 15 | 
| Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) | Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Severity of Four Individual Signs and Symptoms | Erythema, induration/papulation, lichenification and pruritus | Day 15 | 
| Evaluation of Application Site Reactions | Dryness, burning/stinging, erosion, edema, and pain | Day 15 |