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
Omaha, Nebraska 68144
691
mi
from 43215
Omaha, NE
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
1159
mi
from 43215
Denver, CO
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
1137
mi
from 43215
San Antonio, TX
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452
mi
from 43215
Augusta, GA
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Boca Raton, Florida 33486
?
mi
from 43215
Boca Raton, FL
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Brandon, Florida 33511
831
mi
from 43215
Brandon, FL
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Charlottesville, Virginia 22911
278
mi
from 43215
Charlottesville, VA
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Cincinnati, Ohio 45249
84
mi
from 43215
Cincinnati, OH
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Corbin, Kentucky 40701
216
mi
from 43215
Corbin, KY
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166
mi
from 43215
Detroit, MI
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Fort Gratiot, Michigan 48059
214
mi
from 43215
Fort Gratiot, MI
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Henderson, Nevada 89014
1751
mi
from 43215
Henderson, NV
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993
mi
from 43215
Houston, TX
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891
mi
from 43215
Lake Charles, LA
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Miami, Florida 33175
994
mi
from 43215
Miami, FL
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Mobile, Alabama 36608
703
mi
from 43215
Mobile, AL
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North Miami Beach, Florida 33162
983
mi
from 43215
North Miami Beach, FL
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Oceanside, California 92056
1945
mi
from 43215
Oceanside, CA
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Philadelphia, Pennsylvania 19103
416
mi
from 43215
Philadelphia, PA
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Rochester, New York 14623
352
mi
from 43215
Rochester, NY
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San Antonio, Texas 78229
1138
mi
from 43215
San Antonio, TX
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San Diego, California 92123
1951
mi
from 43215
San Diego, CA
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Santa Monica, California 90404
1984
mi
from 43215
Santa Monica, CA
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Snellville, Georgia 30078
425
mi
from 43215
Snellville, GA
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1656
mi
from 43215
Tempe, AZ
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Walla Walla, Washington 99362
1817
mi
from 43215
Walla Walla, WA
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Warren, Michigan 48093
175
mi
from 43215
Warren, MI
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Warren, Ohio 44483
146
mi
from 43215
Warren, OH
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