Safety and Efficacy of IDP-122 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:November 20, 2015
End Date:May 31, 2017

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A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-122 in the Treatment of Plaque Psoriasis

Evaluate the safety and efficacy of a topical lotion when applied once daily to adult
subjects with moderate to severe plaque psoriasis.

A multicenter, double-blind, randomized, parallel-group study designed to assess the safety
and efficacy of IDP-122 Lotion in comparison with its vehicle. To be eligible for the study,
subjects must be at least 18 years of age and have a clinical diagnosis of moderate to severe
psoriasis (defined as an 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 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

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
15
sites
Ann Arbor, Michigan 48103
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Ann Arbor, MI
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Atlanta, Georgia 30301
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Atlanta, GA
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Austin, Texas 78759
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Austin, TX
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Boise, Idaho 83704
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Boise, ID
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Clarkston, Michigan 48346
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Clarkston, MI
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Encinitas, California 92023
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Encinitas, CA
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Encino, California 91436
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Encino, CA
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Hot Springs, Arkansas 71913
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Hot Springs, AR
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Knoxville, Tennessee 37909
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Knoxville, TN
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Las Vegas, Nevada 89101
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Las Vegas, NV
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Raleigh, North Carolina 27601
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Raleigh, NC
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Rockville, Maryland 20850
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Rockville, MD
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San Antonio, Texas 78201
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San Antonio, TX
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Santa Rosa, California 95403
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Santa Rosa, CA
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Spokane, Washington 99201
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Spokane, WA
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