Clinical trial NCT01947491: A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Primus Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Prosoft Clinical
First posted: 2013-09-20
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.


Eligibility criteria: Inclusion Criteria:

* Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
* 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:

* Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
* 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.

Primary outcomes:
measure: Percentage of Participants With Success According to the Investigator Global Assessment (IGA)
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Horizon Research Group, Inc.
state: Alabama
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Encinitas
country: United States
facility: California Dermatology and Clinical Research Institute
state: California
city: Encino
country: United States
facility: Encino Research Center
state: California
city: Fremont
country: United States
facility: Center for Dematology Clinical Research, Inc.
state: California
city: San Diego
country: United States
facility: Skin Surgery Medical Group, Inc.
state: California
city: Santa Rosa
country: United States
facility: Redwood Dermatology Research
state: California
city: Denver
country: United States
facility: Cherry Creek Research, Inc.
state: Colorado
city: Denver
country: United States
facility: Colorado Medical Research Center Inc.
state: Colorado
city: New Haven
country: United States
facility: The Savin Center, PC
state: Connecticut
city: Miami
country: United States
facility: Florida Academic Center Research and Education
state: Florida
city: Miami
country: United States
facility: International Dermatology Research Inc.
state: Florida
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: South Bend
country: United States
facility: South Bend Clinic, LLP
state: Indiana
city: Olathe
country: United States
facility: Compliant Clinical Research Inc.
state: Kansas
city: Louisville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: Rockville
country: United States
facility: Lawrence J. Green, MD, LLC
state: Maryland
city: Ann Arbor
country: United States
facility: David Fivenson, MD, PLC
state: Michigan
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central NJ
state: New Jersey
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: New York
country: United States
facility: Fran Cook-Bolden, MD
state: New York
city: Stony Brook
country: United States
facility: DermResearch Center of New York Stony Brook Medical Park
state: New York
city: High Point
country: United States
facility: Zoe Diane Draelos, MD, PA
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: South Euclid
country: United States
facility: Haber Dermatology & Cosmetic Surgery, Inc.
state: Ohio
city: Greenville
country: United States
facility: Carolina Dermatology of Greenville, PA
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Goodlettsville
country: United States
facility: Rivergate Dermatology Clinical Research Center, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: College Station
country: United States
facility: J & S Studies, Inc.
state: Texas
city: Houston
country: United States
facility: The Center for Skin Research
state: Texas
city: San Antonio
country: United States
facility: Stephen Miller, MD, PA
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
References:
citation: 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.