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 10, 2015
End Date:April 4, 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.

The objective of the study is to evaluate the safety and efficacy of topical IDP-122 Lotion
when applied once daily to adult subjects with moderate to severe plaque psoriasis. The
intent of the study is specifically to evaluate the safety and efficacy of a once daily
application of IDP-122 Lotion in comparison with vehicle.

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).

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
Houston, Texas 77065
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Boynton Beach, Florida 33424
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Boynton Beach, FL
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Clearwater, Florida 33755
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Clearwater, FL
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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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Knoxville, Tennessee 37909
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Knoxville, TN
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New York, New York 10075
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Olathe, Kansas 66051
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Olathe, KS
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Omaha, Nebraska 68022
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Omaha, NE
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Plainfield, Indiana 46168
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Plainfield, IN
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San Antonio, Texas 78201
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San Antonio, TX
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Santa Ana, California 92701
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Santa Ana, CA
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Stony Brook, New York 11790
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Stony Brook, NY
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Tampa, Florida 33601
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Tampa, FL
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West Jordan, Utah 84081
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West Jordan, UT
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