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)
NCT ID: NCT02601703
Last Updated: 2019-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1110 participants
INTERVENTIONAL
2015-08-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tacrolimus Ointment 0.1%
Tacrolimus Ointment 0.1%
apply thin layer of ointment to affected area
Protopic® ointment, 0.1%
Protopic® ointment, 0.1%
apply thin layer of ointment to affected area
Placebo of Tacrolimus Ointment
Placebo of Tacrolimus Ointment
apply thin layer of ointment to affected area
Interventions
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Tacrolimus Ointment 0.1%
apply thin layer of ointment to affected area
Protopic® ointment, 0.1%
apply thin layer of ointment to affected area
Placebo of Tacrolimus Ointment
apply thin layer of ointment to affected area
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Glenmark Pharmaceuticals Ltd. India
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Nikhil Sawant
Role: STUDY_DIRECTOR
Glenmark Pharmaceuticals Ltd
Locations
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Glenmark Investigational Site 49
Tempe, Arizona, United States
Glenmark Investigational Site 31
Anaheim, California, United States
Glenmark Investigational Site 23
Bell Gardens, California, United States
Glenmark Investigational Site 30
Cerritos, California, United States
Glenmark Investigational Site 15
Chula Vista, California, United States
Glenmark Investigational Site 14
La Mesa, California, United States
Glenmark Investigational Site 1
Long Beach, California, United States
Glenmark Investigational Site 17
Oceanside, California, United States
Glenmark Investigational Site 25
Pasadena, California, United States
Glenmark Investigational Site 20
San Ramon, California, United States
Glenmark Investigational Site 44
Santa Ana, California, United States
Glenmark Investigational Site 45
Brooksville, Florida, United States
Glenmark Investigational Site 43
Coral Gables, Florida, United States
Glenmark Investigational Site 34
Doral, Florida, United States
Glenmark Investigational Site 22
Fort Lauderdale, Florida, United States
Glenmark Investigational Site 35
Hialeah, Florida, United States
Glenmark Investigational Site 59
Hialeah Gardens, Florida, United States
Glenmark Investigational Site 11
Miami, Florida, United States
Glenmark Investigational Site 19
Miami, Florida, United States
Glenmark Investigational Site 33
Miami, Florida, United States
Glenmark Investigational Site 40
Miami, Florida, United States
Glenmark Investigational Site 42
Miami, Florida, United States
Glenmark Investigational Site 50
Miami, Florida, United States
Glenmark Investigational Site 51
Miami, Florida, United States
Glenmark Investigational Site 54
Miami, Florida, United States
Glenmark Investigational Site 56
Miami, Florida, United States
Glenmark Investigational Site 58
Miami, Florida, United States
Glenmark Investigational Site7
Miami, Florida, United States
Glenmark Investigational Site 28
Miami Gardens, Florida, United States
Glenmark Investigational Site 29
Miami Lakes, Florida, United States
Glenmark Investigational Site 18
Miramar, Florida, United States
Glenmark Investigational Site 32
North Miami Beach, Florida, United States
Glenmark Investigational Site 48
Orlando, Florida, United States
Glenmark Investigational Site 4
Ormond Beach, Florida, United States
Glenmark Investigational Site 47
Pembroke Pines, Florida, United States
Glenmark Investigational Site 5
Winter Park, Florida, United States
Glenmark Investigational Site 52
Macon, Georgia, United States
Glenmark Investigational Site12
Madisonville, Kentucky, United States
Glenmark Investigational Site 2
Saint Joseph, Missouri, United States
Glenmark Investigational Site 41
Henderson, Nevada, United States
Glenmark Investigational Site 16
Las Vegas, Nevada, United States
Glenmark Investigational Site 9
High Point, North Carolina, United States
Glenmark Investigational Site 46
Wilmington, North Carolina, United States
Glenmark Investigational Site 53
Cincinnati, Ohio, United States
Glenmark Investigational Site 21
Cleveland, Ohio, United States
Glenmark Investigational Site 36
Toledo, Ohio, United States
Glenmark Investigational Site 3
Hazleton, Pennsylvania, United States
Glenmark Investigational Site 57
West Columbia, South Carolina, United States
Glenmark Investigational Site 6
Nashville, Tennessee, United States
Glenmark Investigational Site 60
Baytown, Texas, United States
Glenmark Investigational Site 27
Houston, Texas, United States
Glenmark Investigational Site 39
Houston, Texas, United States
Glenmark Investigational Site 8
Houston, Texas, United States
Glenmark Investigational Site 24
Lampasas, Texas, United States
Glenmark Investigational Site 37
Missouri City, Texas, United States
Glenmark Investigational Site 10
Pflugerville, Texas, United States
Glenmark Investigational Site 13
San Antonio, Texas, United States
Glenmark Investigational Site 26
San Antonio, Texas, United States
Glenmark Investigational Site 55
San Antonio, Texas, United States
Glenmark Investigational Site 38
Sugar Land, Texas, United States
Countries
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Other Identifiers
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GLK-1501
Identifier Type: -
Identifier Source: org_study_id
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