A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis

Completed · Phase 3

Conditions studied: Psoriasis

In brief

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

Key facts

Study ID

NCT01967069

Run by

Primus Pharmaceuticals

People needed

277

Starts

2013-11-01

Expected to finish

2014-07-01

Last updated by the study team

2024-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Coastal Clinical Research, Inc. — Mobile, Alabama, United States
• Hudson Dermatology/Clinical Research Advantage — Tempe, Arizona, United States
• Dermatology Specialists, Inc. — Oceanside, California, United States
• University Clinical Trials, Inc — San Diego, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Horizons Clinical Research Center, LLC — Denver, Colorado, United States
• Skin Care Research, Inc. — Boca Raton, Florida, United States
• MOORE Clinical Research, Inc. — Brandon, Florida, United States
• FXM Research Corop. — Miami, Florida, United States
• Dr. Tory P. Sullivan, MD, PA — North Miami Beach, Florida, United States
• Augusta Centre for Dermatology and Skin Renewal, LLC — Augusta, Georgia, United States
• Gwinnett Clinical Research Center, Inc. — Snellville, Georgia, United States
• MLFKnuckles, MD, PSC — Corbin, Kentucky, United States
• Shondra L. Smith, MD Dermatology & Advanced Aesthetics — Lake Charles, Louisiana, United States
• Henry Ford Medical Center, New Center One — Detroit, Michigan, United States
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States
• Grekin Skin Institute — Warren, Michigan, United States
• Skin Specialists P.C. — Omaha, Nebraska, United States
• Bettencourt Skin Center — Henderson, Nevada, United States
• Skin Search of Rochester, Inc. — Rochester, New York, United States
• Radiant Research, Inc. — Cincinnati, Ohio, United States
• Brodell Medical, Inc. — Warren, Ohio, United States
• Paddington Testing Company, Inc. — Philadelphia, Pennsylvania, United States
• Center for Clinical Studies, LTD, LLP — Houston, Texas, United States
• Dermatology Clinical Research Center of San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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