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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2013
End Date:July 2014

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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


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.
We found this trial at
28
sites
North Miami Beach, Florida 33162
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North Miami Beach, FL
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
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Denver, CO
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
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San Antonio, TX
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Augusta, GA
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Boca Raton, Florida 33486
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Boca Raton, FL
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Brandon, Florida 33511
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Brandon, FL
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Charlottesville, Virginia 22911
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Charlottesville, VA
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Cincinnati, Ohio 45249
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Cincinnati, OH
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Corbin, Kentucky 40701
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Corbin, KY
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Detroit, MI
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Fort Gratiot, Michigan 48059
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Fort Gratiot, MI
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Henderson, Nevada 89014
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Henderson, NV
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Houston, TX
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Lake Charles, LA
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Miami, Florida 33175
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Miami, FL
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Mobile, Alabama 36608
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Mobile, AL
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Oceanside, California 92056
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Oceanside, CA
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Omaha, Nebraska 68144
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Omaha, NE
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Philadelphia, Pennsylvania 19103
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Philadelphia, PA
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Rochester, New York 14623
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Rochester, NY
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San Antonio, Texas 78229
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San Antonio, TX
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San Diego, California 92123
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San Diego, CA
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Santa Monica, California 90404
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Santa Monica, CA
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Snellville, Georgia 30078
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Snellville, GA
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Tempe, AZ
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Walla Walla, Washington 99362
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Walla Walla, WA
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Warren, Michigan 48093
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Warren, MI
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Warren, Ohio 44483
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Warren, OH
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