Study of Generic Pimecrolimus Cream, 1% in the Treatment of Mild to Moderate Atopic Dermatitis
NCT ID: NCT02896101
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
755 participants
INTERVENTIONAL
2016-08-31
2017-06-30
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
QUADRUPLE
Study Groups
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Pimecrolimus Cream, 1%
Pimecrolimus Cream, 1 % (Glenmark Pharmaceuticals Ltd) topical application
Pimecrolimus Cream, 1%
Elidel®
Elidel® (Valeant Pharmaceuticals North America LLC) topical application
Elidel® (pimecrolimus) Cream
Placebo
Placebo of Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) topical application
Placebo of Pimecrolimus Cream, 1%
Interventions
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Pimecrolimus Cream, 1%
Elidel® (pimecrolimus) Cream
Placebo of Pimecrolimus Cream, 1%
Eligibility Criteria
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Inclusion Criteria
* Non-immunocompromised, with a clinical diagnosis of mild to moderate AD that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or for whom those treatments are not advisable.
* Confirmed diagnosis of AD for at least 3 months using the diagnostic features as described by Hanifin and Rajka.
* IGA score of 2 (mild) or 3 (moderate) and ≥ 5% BSA affected at baseline.
Exclusion Criteria
* Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline and history or presence of skin conditions that would interfere with evaluations.
* History or presence of Netherton's Syndrome, immunological deficiencies or diseases, organ transplant, HIV, diabetes, malignancy, malignant or pre-malignant skin conditions, serious active or recurrent infection, systemic immunosuppressive regimens, clinically significant severe renal insufficiency or severe hepatic disorders.
* Use within one month before baseline of 1) oral or intravenous corticosteroids, 2) UVA/UVB therapy, 3) psoralen plus ultraviolet A therapy (PUVA), 4) tanning booths, 5) non-prescription ultraviolet (UV) light sources, 6) immunomodulators or immunosuppressive therapies, 7) interferon, 8) cytotoxic drugs, 9) tacrolimus or 10) pimecrolimus.
* Use within 14 days before baseline of: 1) systemic antibiotics, 2) calcipotriene or other vitamin D preparations, or 3) retinoids.
* Use within 7 days before baseline of: 1) antihistamines, 2) topical antibiotics, 3) topical corticosteroids or 4) other topical drug products.
12 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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Investigational Site 4
Hot Springs, Arkansas, United States
Investigational Site 22
Little Rock, Arkansas, United States
Investigational Site 20
Anaheim, California, United States
Investigational Site 13
Fremont, California, United States
Investigational Site 26
Norco, California, United States
Investigational Site 17
Doral, Florida, United States
Investigational Site 9
Hialeah, Florida, United States
Investigational Site 16
Miami, Florida, United States
Investigational Site 18
Miami, Florida, United States
Investigational Site 19
Miami, Florida, United States
Investigational Site 25
Miami, Florida, United States
Investigational Site 8
Miami, Florida, United States
Investigational Site 12
North Miami Beach, Florida, United States
Investigational Site 3
Ormond Beach, Florida, United States
Investigational Site 7
South Miami, Florida, United States
Investigational Site 10
Tampa, Florida, United States
Investigational Site 24
Tampa, Florida, United States
Investigational Site 14
West Palm Beach, Florida, United States
Investigational Site 1
Arlington Heights, Illinois, United States
Investigational Site 21
Lake Charles, Louisiana, United States
Investigational Site 2
Silver Spring, Maryland, United States
Investigational Site 11
Saint Joseph, Missouri, United States
Investigational Site 27
East Windsor, New Jersey, United States
Investigational Site 5
High Point, North Carolina, United States
Investigational Site 23
Raleigh, North Carolina, United States
Investigational Site 15
Cincinnati, Ohio, United States
Investigational Site 6
Nashville, Tennessee, United States
Countries
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Other Identifiers
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GLK-1601
Identifier Type: -
Identifier Source: org_study_id
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