Psoriasis Clinical Trial

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

Summary

Safety and Efficacy of IDP-118 in the treatment of plaque psoriasis

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Full Description

A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

View Eligibility Criteria

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 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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

215

Study ID:

NCT02462122

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 5
Fremont California, 94536, United States
Valeant Site 2
Boynton Beach Florida, 33424, United States
Valeant Site 14
North Miami Beach Florida, 33160, United States
Valeant Site 13
Detroit Michigan, 48201, United States
Valeant Site 8
Warren Michigan, 48088, United States
Valeant Site 10
Fridley Minnesota, 55421, United States
Valeant Site 1
East Windsor New Jersey, 08520, United States
Valeant Site 4
Albuquerque New Mexico, 87103, United States
Valeant Site 12
New York New York, 10001, United States
Valeant Site 6
High Point North Carolina, 27260, United States
Valeant Site 3
Portland Oregon, 97201, United States
Valeant Site 7
Knoxville Tennessee, 37909, United States
Valeant Site 9
College Station Texas, 77840, United States
Valeant Site 15
Houston Texas, 77001, United States
Valeant Site 16
Houston Texas, 77001, United States
Valeant Site 11
Pflugerville Texas, 78660, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

215

Study ID:

NCT02462122

Recruitment Status:

Completed

Sponsor:


Bausch Health Americas, Inc.

How clear is this clinincal trial information?

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