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

Phase 3

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
IDP-118 Lotion	IDP-118 Lotion	Lotion
IDP-118 Vehicle Lotion	IDP-118 Vehicle Lotion	Vehicle Lotion

Primary Outcome Measures

Name	Time	Method
The Percentage of Participants With Treatment Success at Week 8	8 weeks	Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2	12 weeks	Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.

Locations (16): Valeant Site 16
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Denver, Colorado, United States
Valeant Site 8
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Louisville, Kentucky, United States
Valeant Site 6
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Nashville, Tennessee, United States
Valeant Site 5
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Austin, Texas, United States
Valeant Site 10
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San Diego, California, United States
Valeant Site 13
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Clinton Township, Michigan, United States
Valeant Site 4
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Houston, Texas, United States
Valeant Site 15
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Spokane, Washington, United States
Valeant Site 3
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Mobile, Alabama, United States
Valeant Site 12
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Encino, California, United States
Valeant Site 1
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Santa Rosa, California, United States
Valeant Site 7
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South Bend, Indiana, United States
Valeant Site 14
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Rochester, New York, United States
Valeant Site 9
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Beverly Hills, California, United States
Valeant Site 2
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Tampa, Florida, United States
Valeant Site 11
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Norfolk, Virginia, United States