Psoriasis Clinical Trial

Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis

Summary

This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment [IGA] score of 3 or 4).

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Full Description

This study is 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, participants 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).

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Eligibility Criteria

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 score of 3 or 4 (the face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded from this calculation, 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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

217

Study ID:

NCT02514577

Recruitment Status:

Completed

Sponsor:

Bausch Health Americas, Inc.

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There are 15 Locations for this study

See Locations Near You

Valeant Site 11
Hot Springs Arkansas, 71901, United States
Valeant Site 1
Encinitas California, 92023, United States
Valeant Site 10
Encino California, 91436, United States
Valeant Site 12
Santa Rosa California, 95401, United States
Valeant Site 13
Atlanta Georgia, 30301, United States
Valeant Site 7
Boise Idaho, 83701, United States
Valeant Site 6
Rockville Maryland, 20847, United States
Valeant Site 4
Ann Arbor Michigan, 48103, United States
Valeant Site 8
Clarkston Michigan, 48346, United States
Valeant Site 15
Las Vegas Nevada, 89101, United States
Valeant Site 9
Raleigh North Carolina, 27601, United States
Valeant Site 5
Knoxville Tennessee, 37901, United States
Valeant Site 3
Austin Texas, 73301, United States
Valeant Site 2
San Antonio Texas, 78201, United States
Valeant Site 14
Spokane Washington, 99201, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

217

Study ID:

NCT02514577

Recruitment Status:

Completed

Sponsor:


Bausch Health Americas, Inc.

How clear is this clinincal trial information?

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