Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:2/17/2018
Start Date:August 11, 2015
End Date:April 24, 2017

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A Phase 3, Multicenter, Open Label Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis

The objective of this study is to evaluate the long-term safety of IDP-118 Lotion.

This is a multicenter, open label study of the long-term safety of IDP-118 Lotion in subjects
with plaque psoriasis. To be eligible for the study, subjects must be at least 18 years of
age and have a clinical diagnosis of moderate to severe plaque psoriasis (defined as an
Investigator's Global Assessment [IGA] score of 3 or 4).

Key Inclusion Criteria:

- Male or female, of any race, at least 18 years of age (inclusive).

- Freely provides both verbal and written informed consent.

- Has an area of plaque psoriasis appropriate for topical treatment that covers a Body
Surface Area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms,
soles, axillae and intertriginous areas are to be excluded in this calculation.

- Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet
radiation (natural and artificial) for the duration of the study.

- Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigators
Global Assessment (IGA) score of 3 or 4. (The face, scalp, palms, soles, axillae and
intertriginous areas are to be excluded in this assessment).

Key Exclusion Criteria:

- Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular
psoriasis, as determined by the investigator.

- Presents with psoriasis that was treated with prescription medication and failed to
respond to treatment, even partially or temporarily, as determined by the
investigator.

- Presents with any concurrent skin condition that could interfere with the evaluation
of the treatment areas, as determined by the investigator.

- Is pregnant, nursing an infant, or planning a pregnancy during the study period.

- Has received treatment with any investigational drug or device within 60 days or 5
drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently
participating in another clinical study with an investigational drug or device.
We found this trial at
41
sites
Clinton Township, Michigan 48036
?
mi
from 43215
Clinton Township, MI
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Beverly Hills, California 90210
1979
mi
from 43215
Beverly Hills, CA
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Boynton Beach, Florida 33424
943
mi
from 43215
Boynton Beach, FL
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Charleston, South Carolina 29401
525
mi
from 43215
Charleston, SC
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Coral Gables, Florida 33134
996
mi
from 43215
Coral Gables, FL
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Dallas, Texas 75201
911
mi
from 43215
Dallas, TX
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Detroit, Michigan 48201
164
mi
from 43215
Detroit, MI
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East Windsor, New Jersey
448
mi
from 43215
East Windsor, NJ
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Encinitas, California 92023
1947
mi
from 43215
Encinitas, CA
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Encino, California 91436
1983
mi
from 43215
Encino, CA
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Englewood, Colorado 80113
1162
mi
from 43215
Englewood, CO
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Fridley, Minnesota 55432
629
mi
from 43215
Fridley, MN
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Houston, Texas 77065
991
mi
from 43215
Houston, TX
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Katy, Texas 77449
1008
mi
from 43215
Katy, TX
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Los Angeles, California 90045
1972
mi
from 43215
Los Angeles, CA
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Louisville, Kentucky 40217
189
mi
from 43215
Louisville, KY
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Lynchburg, Virginia 24501
273
mi
from 43215
Lynchburg, VA
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Miami, Florida 33111
993
mi
from 43215
Miami, FL
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Mobile, Alabama 36601
699
mi
from 43215
Mobile, AL
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Nashville, Tennessee 37115
324
mi
from 43215
Nashville, TN
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New York, New York 10075
480
mi
from 43215
New York, NY
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Norfolk, Virginia 23507
423
mi
from 43215
Norfolk, VA
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North Miami Beach, Florida 33162
983
mi
from 43215
North Miami Beach, FL
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Olathe, Kansas 66051
633
mi
from 43215
Olathe, KS
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Omaha, Nebraska 68022
698
mi
from 43215
Omaha, NE
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Pflugerville, Texas 78660
1052
mi
from 43215
Pflugerville, TX
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Philadelphia, Pennsylvania 19019
423
mi
from 43215
Philadelphia, PA
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Portland, Oregon 97201
2027
mi
from 43215
Portland, OR
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Rochester, New York 14623
352
mi
from 43215
Rochester, NY
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Sacramento, California 94203
2043
mi
from 43215
Sacramento, CA
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Salt Lake City, Utah 84117
1513
mi
from 43215
Salt Lake City, UT
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San Antonio, Texas 78201
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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Sanford, Florida 32771
780
mi
from 43215
Sanford, FL
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Santa Monica, California 90404
1986
mi
from 43215
Santa Monica, CA
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Santa Rosa, California 95403
2083
mi
from 43215
Santa Rosa, CA
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Snellville, Georgia 30039
429
mi
from 43215
Snellville, GA
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220 West Colfax Avenue
South Bend, Indiana 46601
206
mi
from 43215
South Bend, IN
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Spokane, Washington 99201
1779
mi
from 43215
Spokane, WA
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Warren, Michigan 48088
176
mi
from 43215
Warren, MI
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Webster, Texas 77598
993
mi
from 43215
Webster, TX
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