Condition: Psoriasis · Sponsor: Primus Pharmaceuticals
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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 | — |
+ 16 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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