Clinical trial NCT01967069: A Comparison of DFD01 Spray Versus Vehicle Spray 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: 2013-10-22
Enrollment: 277
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 efficacy and safety of DFD01 Spray to Vehicle Spray for topical treatment of moderate plaque psoriasis


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.

Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, or alefacept).

Have received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed within 1 year of the Baseline Visit.

Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).

Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, and intranasal steroids are allowed.

Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.

Require use of beta blockers, lithium, ACE inhibitors, and/or NSAIDs (indomethacin, ibuprofen, aspirin, naproxen) with a medical history that these medications affect the subject's psoriasis, except if the subject has been using the medication routinely during the 180 days prior to the Baseline Visit, these medications are allowed.

Primary outcomes:
measure: Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Tempe
country: United States
facility: Hudson Dermatology/Clinical Research Advantage
state: Arizona
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: San Diego
country: United States
facility: University Clinical Trials, Inc
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: Boca Raton
country: United States
facility: Skin Care Research, Inc.
state: Florida
city: Brandon
country: United States
facility: MOORE Clinical Research, Inc.
state: Florida
city: Miami
country: United States
facility: FXM Research Corop.
state: Florida
city: North Miami Beach
country: United States
facility: Dr. Tory P. Sullivan, MD, PA
state: Florida
city: Augusta
country: United States
facility: Augusta Centre for Dermatology and Skin Renewal, LLC
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center, Inc.
state: Georgia
city: Corbin
country: United States
facility: MLFKnuckles, MD, PSC
state: Kentucky
city: Lake Charles
country: United States
facility: Shondra L. Smith, MD Dermatology & Advanced Aesthetics
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Medical Center, New Center One
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Omaha
country: United States
facility: Skin Specialists P.C.
state: Nebraska
city: Henderson
country: United States
facility: Bettencourt Skin Center
state: Nevada
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Warren
country: United States
facility: Brodell Medical, Inc.
state: Ohio
city: Philadelphia
country: United States
facility: Paddington Testing Company, Inc.
state: Pennsylvania
city: Houston
country: United States
facility: Center for Clinical Studies, LTD, LLP
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Reesearch, PA
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
city: Walla Walla
country: United States
facility: Eastern Washington Dermatology
state: Washington
Study officials:
References: