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

Completed · Phase 3

Conditions studied: Plaque Psoriasis

In brief

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).

Key facts

Study ID

NCT02515097

Run by

Bausch Health Americas, Inc.

People needed

213

Starts

2015-11-05

Expected to finish

2017-03-15

Last updated by the study team

2020-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Valeant Site 14 — Santa Ana, California, United States
• Valeant Site 02 — Boynton Beach, Florida, United States
• Valeant Site 10 — Clearwater, Florida, United States
• Valeant Site 1 — Tampa, Florida, United States
• Valeant Site 07 — Plainfield, Indiana, United States
• Valeant Site 15 — Olathe, Kansas, United States
• Valeant Site 08 — Fridley, Minnesota, United States
• Valeant Site 13 — Omaha, Nebraska, United States
• Valeant Site 04 — New York, New York, United States
• Valeant Site 12 — Stony Brook, New York, United States
• Valeant Site 05 — High Point, North Carolina, United States
• Valeant Site 11 — Knoxville, Tennessee, United States
• Valeant Site 03 — Houston, Texas, United States
• Valeant Site 09 — San Antonio, Texas, United States
• Valeant Site 06 — West Jordan, Utah, United States

Full record on ClinicalTrials.gov

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