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)
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT02601703
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd. India
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1110
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tacrolimus Ointment 0.1% Tacrolimus Ointment 0.1% - Protopic® ointment, 0.1% Protopic® ointment, 0.1% - Placebo of Tacrolimus Ointment Placebo of Tacrolimus Ointment -
- Primary Outcome Measures
Name Time Method Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment Day 15
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (60)
Glenmark Investigational Site 49
🇺🇸Tempe, Arizona, United States
Glenmark Investigational Site 31
🇺🇸Anaheim, California, United States
Glenmark Investigational Site 35
🇺🇸Hialeah, Florida, United States
Glenmark Investigational Site 29
🇺🇸Miami Lakes, Florida, United States
Glenmark Investigational Site 2
🇺🇸Saint Joseph, Missouri, United States
Glenmark Investigational Site 38
🇺🇸Sugar Land, Texas, United States
Glenmark Investigational Site 52
🇺🇸Macon, Georgia, United States
Glenmark Investigational Site 5
🇺🇸Winter Park, Florida, United States
Glenmark Investigational Site 30
🇺🇸Cerritos, California, United States
Glenmark Investigational Site 47
🇺🇸Pembroke Pines, Florida, United States
Glenmark Investigational Site 24
🇺🇸Lampasas, Texas, United States
Glenmark Investigational Site 16
🇺🇸Las Vegas, Nevada, United States
Glenmark Investigational Site 34
🇺🇸Doral, Florida, United States
Glenmark Investigational Site 9
🇺🇸High Point, North Carolina, United States
Glenmark Investigational Site 46
🇺🇸Wilmington, North Carolina, United States
Glenmark Investigational Site 57
🇺🇸West Columbia, South Carolina, United States
Glenmark Investigational Site 18
🇺🇸Miramar, Florida, United States
Glenmark Investigational Site12
🇺🇸Madisonville, Kentucky, United States
Glenmark Investigational Site 21
🇺🇸Cleveland, Ohio, United States
Glenmark Investigational Site 28
🇺🇸Miami Gardens, Florida, United States
Glenmark Investigational Site 17
🇺🇸Oceanside, California, United States
Glenmark Investigational Site 20
🇺🇸San Ramon, California, United States
Glenmark Investigational Site 45
🇺🇸Brooksville, Florida, United States
Glenmark Investigational Site 44
🇺🇸Santa Ana, California, United States
Glenmark Investigational Site 22
🇺🇸Fort Lauderdale, Florida, United States
Glenmark Investigational Site 43
🇺🇸Coral Gables, Florida, United States
Glenmark Investigational Site 11
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 40
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 50
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 42
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 56
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 51
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 54
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 32
🇺🇸North Miami Beach, Florida, United States
Glenmark Investigational Site 4
🇺🇸Ormond Beach, Florida, United States
Glenmark Investigational Site 41
🇺🇸Henderson, Nevada, United States
Glenmark Investigational Site 53
🇺🇸Cincinnati, Ohio, United States
Glenmark Investigational Site 3
🇺🇸Hazleton, Pennsylvania, United States
Glenmark Investigational Site 27
🇺🇸Houston, Texas, United States
Glenmark Investigational Site 6
🇺🇸Nashville, Tennessee, United States
Glenmark Investigational Site 36
🇺🇸Toledo, Ohio, United States
Glenmark Investigational Site 60
🇺🇸Baytown, Texas, United States
Glenmark Investigational Site 37
🇺🇸Missouri City, Texas, United States
Glenmark Investigational Site 8
🇺🇸Houston, Texas, United States
Glenmark Investigational Site 26
🇺🇸San Antonio, Texas, United States
Glenmark Investigational Site 13
🇺🇸San Antonio, Texas, United States
Glenmark Investigational Site 55
🇺🇸San Antonio, Texas, United States
Glenmark Investigational Site 59
🇺🇸Hialeah Gardens, Florida, United States
Glenmark Investigational Site 1
🇺🇸Long Beach, California, United States
Glenmark Investigational Site7
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 25
🇺🇸Pasadena, California, United States
Glenmark Investigational Site 15
🇺🇸Chula Vista, California, United States
Glenmark Investigational Site 23
🇺🇸Bell Gardens, California, United States
Glenmark Investigational Site 14
🇺🇸La Mesa, California, United States
Glenmark Investigational Site 19
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 33
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 39
🇺🇸Houston, Texas, United States
Glenmark Investigational Site 58
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 10
🇺🇸Pflugerville, Texas, United States
Glenmark Investigational Site 48
🇺🇸Orlando, Florida, United States