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Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion (0.01% Halobetasol Propionate) to Ultravate® (Halobetasol Propionate) Cream, in the Treatment of Plaque Psoriasis

NCT02785185•Bausch Health Americas, Inc.

View on ClinicalTrials.gov

Summary

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.

Detailed Description

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion (0.01% halobetasol propionate) to Ultravate® (halobetasol propionate) Cream, 0.05% in the Treatment of Plaque Psoriasis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or female, of any race, at least 18 years of age (inclusive).
•Freely provides both verbal and written informed consent.
•Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
•Subject is willing to comply with study instructions and return to the clinic for required visits.

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.

Locations (13)

Valeant Site 05

Rogers, Arkansas, United States

Valeant Site 10

Beverly Hills, California, United States

Valeant Site 09

Carlsbad, California, United States

Valeant Site 13

Los Angeles, California, United States

Valeant Site 12

Santa Monica, California, United States

Valeant Site 07

Coral Gables, Florida, United States

Valeant Site 11

North Miami Beach, Florida, United States

Valeant Site 03

Sanford, Florida, United States

Valeant Site 08

Albany, Indiana, United States

Valeant Site 04

Louisville, Kentucky, United States

Key Dates

Start Date

June 1, 2016

Primary Completion Date

December 2, 2016

Completion Date

January 1, 2017

Last Updated

August 27, 2020

Enrollment

150

ACTUAL participants

Conditions

Psoriasis

Interventions

IDP-122 Vehicle Lotion

DRUG

IDP-122 Vehicle Cream

DRUG

IDP-122 Lotion

DRUG

Ultravate Cream

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

View study

RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

View study

RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments