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

The objective of the study is to evaluate the safety and efficacy of topical IDP-122 Lotion when applied once daily to adult participants 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.

View Eligibility Criteria

Eligibility Criteria

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 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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

213

Study ID:

NCT02515097

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 14
Santa Ana California, 92701, United States
Valeant Site 02
Boynton Beach Florida, 33424, United States
Valeant Site 10
Clearwater Florida, 33755, United States
Valeant Site 1
Tampa Florida, 33603, United States
Valeant Site 07
Plainfield Indiana, 46168, United States
Valeant Site 15
Olathe Kansas, 66051, United States
Valeant Site 08
Fridley Minnesota, 55421, United States
Valeant Site 13
Omaha Nebraska, 68022, United States
Valeant Site 04
New York New York, 10001, United States
Valeant Site 12
Stony Brook New York, 11790, United States
Valeant Site 05
High Point North Carolina, 27260, United States
Valeant Site 11
Knoxville Tennessee, 37901, United States
Valeant Site 03
Houston Texas, 77001, United States
Valeant Site 09
San Antonio Texas, 78201, United States
Valeant Site 06
West Jordan Utah, 84081, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

213

Study ID:

NCT02515097

Recruitment Status:

Completed

Sponsor:


Bausch Health Americas, Inc.

How clear is this clinincal trial information?

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