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
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New York, New York 10075
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Beverly Hills, California 90210
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Boynton Beach, Florida 33424
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Charleston, South Carolina 29401
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Clinton Township, Michigan 48036
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Coral Gables, Florida 33134
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Dallas, Texas 75201
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Detroit, Michigan 48201
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East Windsor, New Jersey
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Encinitas, California 92023
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Encino, California 91436
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Englewood, Colorado 80113
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Fridley, Minnesota 55432
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Houston, Texas 77065
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Katy, Texas 77449
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Los Angeles, California 90045
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Louisville, Kentucky 40217
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Lynchburg, Virginia 24501
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Miami, Florida 33111
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Mobile, Alabama 36601
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Nashville, Tennessee 37115
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Norfolk, Virginia 23507
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North Miami Beach, Florida 33162
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Olathe, Kansas 66051
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Omaha, Nebraska 68022
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Pflugerville, Texas 78660
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Philadelphia, Pennsylvania 19019
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Portland, Oregon 97201
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Rochester, New York 14623
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Sacramento, California 94203
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Salt Lake City, Utah 84117
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San Antonio, Texas 78201
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San Diego, California 92123
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Sanford, Florida 32771
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Santa Monica, California 90404
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Santa Rosa, California 95403
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Snellville, Georgia 30039
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220 West Colfax Avenue
South Bend, Indiana 46601
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Spokane, Washington 99201
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Warren, Michigan 48088
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Webster, Texas 77598
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