A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis
NCT ID: NCT01947491
Last Updated: 2024-03-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
394 participants
INTERVENTIONAL
2013-11-30
2015-01-31
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
DOUBLE
Study Groups
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DFD01 Spray
DFD01 Spray twice daily for 28 days
DFD01 Spray
Vehicle Spray
Vehicle Spray twice daily for 28 days
Vehicle Spray
Comp01 Lotion
Comp01 Lotion twice daily for 14 days
Comp01 Lotion
Vehicle Lotion
Vehicle Lotion twice daily for 28 days
Vehicle Lotion
Interventions
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DFD01 Spray
Comp01 Lotion
Vehicle Lotion
Vehicle Spray
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
* Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit
Exclusion Criteria
* Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
* Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
* History of psoriasis unresponsive to topical treatments.
* History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
18 Years
ALL
No
Sponsors
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Prosoft Clinical
OTHER
Primus Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Horizon Research Group, Inc.
Mobile, Alabama, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
California Dermatology and Clinical Research Institute
Encinitas, California, United States
Encino Research Center
Encino, California, United States
Center for Dematology Clinical Research, Inc.
Fremont, California, United States
Skin Surgery Medical Group, Inc.
San Diego, California, United States
Redwood Dermatology Research
Santa Rosa, California, United States
Cherry Creek Research, Inc.
Denver, Colorado, United States
Colorado Medical Research Center Inc.
Denver, Colorado, United States
The Savin Center, PC
New Haven, Connecticut, United States
Florida Academic Center Research and Education
Miami, Florida, United States
International Dermatology Research Inc.
Miami, Florida, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
South Bend Clinic, LLP
South Bend, Indiana, United States
Compliant Clinical Research Inc.
Olathe, Kansas, United States
Dermatology Specialists Research
Louisville, Kentucky, United States
Lawrence J. Green, MD, LLC
Rockville, Maryland, United States
David Fivenson, MD, PLC
Ann Arbor, Michigan, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, United States
Psoriasis Treatment Center of Central NJ
East Windsor, New Jersey, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Fran Cook-Bolden, MD
New York, New York, United States
DermResearch Center of New York Stony Brook Medical Park
Stony Brook, New York, United States
Zoe Diane Draelos, MD, PA
High Point, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Haber Dermatology & Cosmetic Surgery, Inc.
South Euclid, Ohio, United States
Carolina Dermatology of Greenville, PA
Greenville, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Rivergate Dermatology Clinical Research Center, PLLC
Goodlettsville, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
DermResearch, Inc.
Austin, Texas, United States
J & S Studies, Inc.
College Station, Texas, United States
The Center for Skin Research
Houston, Texas, United States
Stephen Miller, MD, PA
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
Countries
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References
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Sidgiddi S, Pakunlu RI, Allenby K. Efficacy, Safety, and Potency of Betamethasone Dipropionate Spray 0.05%: A Treatment for Adults with Mild-to-moderate Plaque Psoriasis. J Clin Aesthet Dermatol. 2018 Apr;11(4):14-22. Epub 2018 Apr 1.
Other Identifiers
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1205
Identifier Type: -
Identifier Source: org_study_id
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