Psoriasis Clinical Trial

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

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

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

277

Study ID:

NCT01967069

Recruitment Status:

Completed

Sponsor:

Primus Pharmaceuticals

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There are 27 Locations for this study

See Locations Near You

Coastal Clinical Research, Inc.
Mobile Alabama, 36608, United States
Hudson Dermatology/Clinical Research Advantage
Tempe Arizona, 85282, United States
Dermatology Specialists, Inc.
Oceanside California, 92056, United States
University Clinical Trials, Inc
San Diego California, 92123, United States
Clinical Science Institute
Santa Monica California, 90404, United States
Horizons Clinical Research Center, LLC
Denver Colorado, 80220, United States
Skin Care Research, Inc.
Boca Raton Florida, 33486, United States
MOORE Clinical Research, Inc.
Brandon Florida, 33511, United States
FXM Research Corop.
Miami Florida, 33175, United States
Dr. Tory P. Sullivan, MD, PA
North Miami Beach Florida, 33162, United States
Augusta Centre for Dermatology and Skin Renewal, LLC
Augusta Georgia, 30909, United States
Gwinnett Clinical Research Center, Inc.
Snellville Georgia, 30078, United States
MLFKnuckles, MD, PSC
Corbin Kentucky, 40701, United States
Shondra L. Smith, MD Dermatology & Advanced Aesthetics
Lake Charles Louisiana, 70605, United States
Henry Ford Medical Center, New Center One
Detroit Michigan, 48202, United States
Hamzavi Dermatology
Fort Gratiot Michigan, 48059, United States
Grekin Skin Institute
Warren Michigan, 48088, United States
Skin Specialists P.C.
Omaha Nebraska, 68144, United States
Bettencourt Skin Center
Henderson Nevada, 89074, United States
Skin Search of Rochester, Inc.
Rochester New York, 14623, United States
Radiant Research, Inc.
Cincinnati Ohio, 45249, United States
Brodell Medical, Inc.
Warren Ohio, 44483, United States
Paddington Testing Company, Inc.
Philadelphia Pennsylvania, 19103, United States
Center for Clinical Studies, LTD, LLP
Houston Texas, 77004, United States
Dermatology Clinical Research Center of San Antonio
San Antonio Texas, 78229, United States
Progressive Clinical Reesearch, PA
San Antonio Texas, 78229, United States
Charlottesville Medical Research Center, LLC
Charlottesville Virginia, 22911, United States
Eastern Washington Dermatology
Walla Walla Washington, 99362, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

277

Study ID:

NCT01967069

Recruitment Status:

Completed

Sponsor:


Primus Pharmaceuticals

How clear is this clinincal trial information?

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