To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin)

Study Overview
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Brief Summary
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This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (Tacrolimus) Ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD)

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Tacrolimus Ointment 0.1%
* Drug: Protopic® ointment, 0.1%
* Drug: Placebo of Tacrolimus Ointment


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Non-immunocompromised male or non-pregnant, non-lactating female, 18 years of age or older with a clinical diagnosis of moderate to severe AD. Have confirmed diagnosis of atopic dermatitis for at least 3 months using the diagnostic features as described by Hanifin and Rajka Have an IGA score of 3 (moderate) or 4 (severe). Have an affected Body Surface Area (BSA) of at least 20% at baseline. Treated with a bland emollient for at least 7 days. Key Exclusion Criteria: Active cutaneous bacterial or viral infection in any treatment area at baseline. Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline. History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis. 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. Known allergy or hypersensitivity to tacrolimus or any other component of the Study products.

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tacrolimus Ointment 0.1%<br> | Drug: Tacrolimus Ointment 0.1%<br>* apply thin layer of ointment to affected area<br>|
| Active Comparator: Protopic® ointment, 0.1%<br> | Drug: Protopic® ointment, 0.1%<br>* apply thin layer of ointment to affected area<br>|
| Placebo Comparator: Placebo of Tacrolimus Ointment<br> | Drug: Placebo of Tacrolimus Ointment<br>* apply thin layer of ointment to affected area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment |  | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in severity score from baseline to study Day 15 of the four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification and pruritus). |  | Day 15 |