Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis
NCT ID: NCT03107611
Last Updated: 2022-03-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
654 participants
INTERVENTIONAL
2016-02-29
2017-05-15
Brief Summary
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To establish superiority of each active treatment over the placebo.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days
Placebo Cream
Test
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
Reference Standard
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
Interventions
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Pimecrolimus Cream, 1%
Placebo Cream
Pimecrolimus Cream, 1%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of mild to moderate Atopic Dermatitis (AD)
* Failed to respond adequately to other topical prescription treatments for AD, or for whom those treatments are not advisable.
* A diagnosis of AD for at least 3 months
* An Investigator's Global Assessment (IGA) of disease severity of mild or moderate at baseline (score of 2 or 3)
* Affected area of AD involvement at least 5% body surface area (BSA)
* Treated with a bland emollient for at least 7 days
Exclusion Criteria
* Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected atopic dermatitis, impetigo).
* Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations
* History or presence of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, ichthyosis, or scabies.
* 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
* Concurrent disease or treatment likely to interfere with the study treatment or evaluations
* Known allergy or hypersensitivity to pimecrolimus or any other component of the drug products
* Not willing to minimize or avoid natural and artificial sunlight exposure during treatment
8 Years
ALL
No
Sponsors
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DPT Laboratories, Ltd.
INDUSTRY
Mylan Inc.
INDUSTRY
Responsible Party
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Locations
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Research Facility 6
Boynton Beach, Florida, United States
Research Facility 4
Coral Gables, Florida, United States
Research Facility 5
Miami, Florida, United States
Research Facility 10
Miami, Florida, United States
Research Facility 1
Miami Lakes, Florida, United States
Research Facility 9
Miramar, Florida, United States
Research Facility 33
Sweetwater, Florida, United States
Research Facility 23
Boise, Idaho, United States
Research Facility 28
Overland Park, Kansas, United States
Research Facility 32
Louisville, Kentucky, United States
Research Facility 13
New Orleans, Louisiana, United States
Research Facility 7
Saint Joseph, Missouri, United States
Research Facility 19
Omaha, Nebraska, United States
Research Facility 29
Albuquerque, New Mexico, United States
Research Facility 24
Charlotte, North Carolina, United States
Research Facility 2
High Point, North Carolina, United States
Resarch Facility 8
Philadelphia, Pennsylvania, United States
Research Facility 18
Johnston, Rhode Island, United States
Research Facility 20
Austin, Texas, United States
Research Facility 16
College Station, Texas, United States
Research Facility 31
Pflugerville, Texas, United States
Research Facility 17
Sugar Land, Texas, United States
Research Facility 22
West Jordan, Utah, United States
Research Facility 15
Richmond, Virginia, United States
Research Facility 26
Spokane, Washington, United States
Research Facility 11
Santo Domingo, , Dominican Republic
Research Facility 12
San Pedro Sula, , Honduras
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CD-14-875
Identifier Type: -
Identifier Source: org_study_id
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