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

August 19, 2020 updated by: Bausch Health Americas, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Rogers, Arkansas, United States, 75758
        • Valeant Site 05
    • California
      • Beverly Hills, California, United States, 90210
        • Valeant Site 10
      • Carlsbad, California, United States, 92008
        • Valeant Site 09
      • Los Angeles, California, United States, 90045
        • Valeant Site 13
      • Santa Monica, California, United States, 90404
        • Valeant Site 12
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Valeant Site 07
      • North Miami Beach, Florida, United States, 33162
        • Valeant Site 11
      • Sanford, Florida, United States, 32771
        • Valeant Site 03
    • Indiana
      • Albany, Indiana, United States, 47150
        • Valeant Site 08
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Valeant Site 04
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Valeant Site 06
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Valeant Site 02
    • Texas
      • Houston, Texas, United States, 77065
        • Valeant Site 01

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDP-122 Lotion
Lotion
Drug: IDP-122 Lotion
Lotion
Other Names:
  • Lotion
Active Comparator: Ultravate Cream
Cream
Drug: Ultravate Cream
Cream
Other Names:
  • Ultravate
Active Comparator: IDP-122 Vehicle Lotion
Lotion
Drug: IDP-122 Vehicle Lotion
Vehicle
Other Names:
  • Lotion
Active Comparator: IDP-122 Vehicle Cream
Cream
Drug: IDP-122 Vehicle Cream
Vehicle
Other Names:
  • Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 2
Time Frame: 2 weeks
Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Week 2. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Investigators

  • Study Director: Binu J Alexander, MD, Valeant Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

December 2, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Actual)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V01-122A-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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