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

Use our guide to learn which trials are right for you!

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
Long Beach, California
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Anaheim, California
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
?
mi
from
Baytown, TX
Click here to add this to my saved trials
Bell Gardens, California
?
mi
from
Bell Gardens, CA
Click here to add this to my saved trials
Brooksville, Florida
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
Cerritos, California
?
mi
from
Cerritos, CA
Click here to add this to my saved trials
Chula Vista, California
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Coral Gables, Florida
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
?
mi
from
Doral, FL
Click here to add this to my saved trials
Fort Lauderdale, Florida
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Hazleton, Pennsylvania
?
mi
from
Hazleton, PA
Click here to add this to my saved trials
?
mi
from
Henderson, NV
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hialeah Gardens, Florida
?
mi
from
Hialeah Gardens, FL
Click here to add this to my saved trials
High Point, North Carolina
?
mi
from
High Point, NC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
La Mesa, California
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
?
mi
from
Lampasas, TX
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Macon, GA
Click here to add this to my saved trials
Madisonville, Kentucky 42431
?
mi
from
Madisonville, KY
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Gardens, Florida
?
mi
from
Miami Gardens, FL
Click here to add this to my saved trials
Miami Lakes, Florida
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
?
mi
from
Miramar, FL
Click here to add this to my saved trials
Missouri City, Texas
?
mi
from
Missouri City, TX
Click here to add this to my saved trials
Nashville, Tennessee
?
mi
from
Nashville, TN
Click here to add this to my saved trials
North Miami Beach, Florida
?
mi
from
North Miami Beach, FL
Click here to add this to my saved trials
Oceanside, California
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Ormond Beach, Florida
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
Pasadena, California
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
Pembroke Pines, Florida
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
Pflugerville, Texas
?
mi
from
Pflugerville, TX
Click here to add this to my saved trials
San Antonio, Texas
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Ramon, California
?
mi
from
San Ramon, CA
Click here to add this to my saved trials
Santa Ana, California
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
St. Joseph, Missouri
?
mi
from
St. Joseph, MO
Click here to add this to my saved trials
?
mi
from
Sugarland, TX
Click here to add this to my saved trials
?
mi
from
Tempe, AZ
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials
West Columbia, South Carolina 29169
?
mi
from
West Columbia, SC
Click here to add this to my saved trials
Wilmington, North Carolina
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
Winter Park, Florida
?
mi
from
Winter Park, FL
Click here to add this to my saved trials