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
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Katy, Texas 77449
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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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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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New York, New York 10075
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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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South Bend, IN
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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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