A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis

Completed · Phase 3

Conditions studied: Chronic Stable Plaque Psoriasis

In brief

This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.

Key facts

Study ID

NCT02445807

Run by

Promius Pharma, LLC

People needed

265

Starts

2015-12-01

Expected to finish

2016-07-01

Last updated by the study team

2018-05-15

Who can join

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

You may qualify if…

• Subject understands the study procedures and agrees to participate by giving written informed consent. Subjects must be willing to authorize use and disclosure of protected health information collected for the study.
• Subject must be at least 18 years of age.
• Subject must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
• Subject with psoriasis involving 3% or greater BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
• Subject must have an IGA grade of 3 or 4 (moderate to severe) at the Baseline Visit.
• Female subjects of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the subject become sexually active. All women of childbearing potential must complete a urine pregnancy test (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) at the Baseline Visit (Visit 2) and the test result must be negative to be eligible for enrollment.
• Subject must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).

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 biological or 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, secukinumab, 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 if at least 1 year before the Baseline Visit.
• Use within 60 days prior to the Baseline Visit of: 1) systemic or topical 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.
• Subjects who have participated in a study of an investigational drug 60 days prior to the Baseline Visit.

Where it is running

• Site 101 — Birmingham, Alabama, United States
• Site 103 — Mobile, Alabama, United States
• Site 130 — Mesa, Arizona, United States
• Site 116 — Phoenix, Arizona, United States
• Site 125 — Tucson, Arizona, United States
• Site 120 — North Hollywood, California, United States
• Site 114 — San Diego, California, United States
• Site 127 — Santa Monica, California, United States
• Site 128 — Clearwater, Florida, United States
• Site 115 — Miami, Florida, United States
• Site 118 — Indianapolis, Indiana, United States
• Site 110 — Louisville, Kentucky, United States
• Site 105 — Glenn Dale, Maryland, United States
• Site 111 — Warren, Michigan, United States
• Site 113 — Fridley, Minnesota, United States
• Site 123 — Saint Joseph, Missouri, United States
• Site 106 — Newington, New Hampshire, United States
• Site 104 — Albuquerque, New Mexico, United States
• Site 117 — Stony Brook, New York, United States
• Site 124 — High Point, North Carolina, United States
• Site 109 — Winston-Salem, North Carolina, United States
• Site 129 — Johnston, Rhode Island, United States
• Site 119 — Anderson, South Carolina, United States
• Site 102 — Greenville, South Carolina, United States
• Site 108 — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.