Safety and Efficacy 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:12/17/2017
Start Date:February 2016
End Date:December 2016

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A Phase 2, Multicenter, Double Blinded, Randomized, Vehicle Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis

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

A Phase 2, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Study to Compare the
Safety and Efficacy of IDP-118 Lotion in the Treatment of 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 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 (IGA) Investigator
Global Assessment score of 3 or 4. (The face, scalp, palms, soles, axillae and
intertriginous areas are to be excluded in this assessment, if psoriasis is present.)

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
13
sites
Tampa, Florida 33601
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Charlottesville, Virginia 22901
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Clarkston, Michigan 48346
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College Station, Texas 77845
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Encino, California 91436
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Encino, CA
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Fridley, Minnesota 55432
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Fridley, MN
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Greenville, South Carolina 29601
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Greenville, SC
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Murfreesboro, Tennessee 37129
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Murfreesboro, TN
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Orange Park, Florida 32065
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Orange Park, FL
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Pinellas Park, Florida 33780
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Pinellas Park, FL
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Plainfield, Indiana 46168
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Plainfield, IN
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Saint Joseph, Missouri 64501
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Saint Joseph, MO
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Webster, Texas 77598
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Webster, TX
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