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)



Status:Recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:7/8/2016
Start Date:August 2015
End Date:December 2016
Contact:Aimee Brown
Email:abrown@novumprs.com
Phone:(412) 363-3300

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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)

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).


Key Inclusion Criteria:

1. Non-immunocompromised male or non-pregnant, non-lactating female, 18 years of age or
older with a clinical diagnosis of moderate to severe AD.

2. Have confirmed diagnosis of atopic dermatitis for at least 3 months using the
diagnostic features as described by Hanifin and Rajka

3. Have an IGA score of 3 (moderate) or 4 (severe).

4. Have an affected Body Surface Area (BSA) of at least 20% at baseline.

5. Treated with a bland emollient for at least 7 days.

Key Exclusion Criteria:

1. Active cutaneous bacterial or viral infection in any treatment area at baseline.

2. Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at
baseline.

3. History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or
ichthyosis.

4. 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.

5. Known allergy or hypersensitivity to tacrolimus or any other component of the Study
products.
We found this trial at
54
sites
Bell Gardens, California
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Anaheim, California
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Anaheim, CA
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Baytown, TX
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Brooksville, Florida
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Brooksville, FL
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Cerritos, California
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Cerritos, CA
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Chula Vista, California
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Chula Vista, CA
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Cincinnati, OH
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Cleveland, OH
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Coral Gables, Florida
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Coral Gables, FL
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Doral, FL
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Fort Lauderdale, Florida
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Hazleton, Pennsylvania
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Hazleton, PA
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Henderson, NV
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Hialeah, FL
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Hialeah Gardens, Florida
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High Point, North Carolina
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High Point, NC
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Houston, TX
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Houston, TX
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Houston, TX
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La Mesa, California
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La Mesa, CA
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Lampasas, TX
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Las Vegas, NV
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Long Beach, California
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Long Beach, CA
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Macon, GA
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Madisonville, Kentucky 42431
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Madisonville, KY
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Miami, FL
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Miami, FL
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Miami, FL
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Miami, FL
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Miami, FL
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Miami, FL
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Miami Gardens, Florida
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Miami Gardens, FL
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Miami Lakes, Florida
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Miami Lakes, FL
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Miramar, FL
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Missouri City, Texas
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Missouri City, TX
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Nashville, Tennessee
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Nashville, TN
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North Miami Beach, Florida
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North Miami Beach, FL
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Oceanside, California
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Oceanside, CA
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Orlando, FL
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Ormond Beach, Florida
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Pasadena, California
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Pasadena, CA
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Pembroke Pines, Florida
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Pflugerville, Texas
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Pflugerville, TX
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San Antonio, Texas
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San Antonio, TX
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San Antonio, Texas
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San Antonio, TX
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San Ramon, California
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San Ramon, CA
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Santa Ana, California
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Santa Ana, CA
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St. Joseph, Missouri
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St. Joseph, MO
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Sugarland, TX
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Tempe, AZ
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Toledo, OH
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West Columbia, South Carolina 29169
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West Columbia, SC
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Wilmington, North Carolina
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Wilmington, NC
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Winter Park, Florida
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Winter Park, FL
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