Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:2/17/2018
Start Date:June 2016
End Date:January 2017

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A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion to Ultravate® (Halobetasol Propionate) Cream, in the Treatment of Plaque Psoriasis

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the
Safety and Efficacy of IDP-122 Lotion to Ultravate® (halobetasol propionate) Cream, 0.05% 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.

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

- Subject is willing to comply with study instructions and return to the clinic for
required visits.

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
Carlsbad, California 92008
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Albany, Indiana 47150
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Albany, IN
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Beverly Hills, California 90210
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Coral Gables, Florida 33134
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Fridley, Minnesota 55432
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High Point, North Carolina 27262
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High Point, NC
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Houston, Texas 77065
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Houston, TX
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Los Angeles, California 90045
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Los Angeles, CA
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Louisville, Kentucky 40217
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Louisville, KY
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North Miami Beach, Florida 33162
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North Miami Beach, FL
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Rogers, Arkansas 75758
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Rogers, AR
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Sanford, Florida 32771
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Sanford, FL
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Santa Monica, California 90404
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Santa Monica, CA
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