Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:August 11, 2015
End Date:December 1, 2016

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A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

The objective of the study is to evaluate the safety and efficacy of a topical lotion.

The objective of the study is to evaluate the safety and efficacy of a topical lotion when
applied once daily to adult subjects with moderate to severe plaque psoriasis.

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 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 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
16
sites
Rochester, New York 14623
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Rochester, NY
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Austin, Texas 78759
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Austin, TX
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Beverly Hills, California 90210
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Beverly Hills, CA
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Clinton Township, Michigan 48036
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Clinton Township, MI
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Denver, Colorado 80123
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Denver, CO
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Encino, California 91436
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Encino, CA
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Houston, Texas 77065
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Houston, TX
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Louisville, Kentucky 40217
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Louisville, KY
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Mobile, Alabama 36601
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Mobile, AL
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Nashville, Tennessee 37115
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Nashville, TN
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Norfolk, Virginia 23507
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Norfolk, VA
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San Diego, California 92123
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San Diego, CA
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Santa Rosa, California 95403
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Santa Rosa, CA
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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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Spokane, WA
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Tampa, Florida 33601
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Tampa, FL
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