Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis

January 14, 2020 updated by: Bausch Health Americas, Inc.

A Phase 3, Multicenter, Open Label Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis

The objective of this study is to evaluate the long-term safety of IDP-118 lotion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multicenter, open-label study of the long-term safety of IDP-118 lotion in participants with plaque psoriasis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
555

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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
    • Alabama
      • Mobile, Alabama, United States, 36603
        • Valeant Site 6
    • California
      • Beverly Hills, California, United States, 90210
        • Valeant Site 24
      • Encinitas, California, United States, 92023
        • Valeant Site 32
      • Encino, California, United States, 91436
        • Valeant Site 27
      • Los Angeles, California, United States, 90001
        • Valeant Site 33
      • Los Angeles, California, United States, 90002
        • Valeant Site 43
      • Sacramento, California, United States, 94203
        • Valeant Site 45
      • San Diego, California, United States, 92093
        • Valeant Site 25
      • San Diego, California, United States, 92093
        • Valeant Site 4
      • Santa Monica, California, United States, 90401
        • Valeant Site 44
      • Santa Rosa, California, United States, 95401
        • Valeant Site 36
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Valeant Site 10
    • Florida
      • Boynton Beach, Florida, United States, 33424
        • Valeant Site 3
      • Coral Gables, Florida, United States, 33134
        • Valeant Site 28
      • Miami, Florida, United States, 33101
        • Valeant Site 1
      • North Miami Beach, Florida, United States, 33160
        • Valeant Site 37
      • Sanford, Florida, United States, 32771
        • Valeant Site 13
    • Georgia
      • Snellville, Georgia, United States, 30039
        • Valeant Site 41
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Valeant Site 17
    • Kansas
      • Olathe, Kansas, United States, 66051
        • Valeant Site 12
    • Kentucky
      • Louisville, Kentucky, United States, 40201
        • Valeant Site 19
      • Louisville, Kentucky, United States, 40205
        • Valeant Site 14
    • Michigan
      • Clinton Township, Michigan, United States, 48036
        • Valeant Site 35
      • Detroit, Michigan, United States, 48201
        • Valeant Site 34
      • Warren, Michigan, United States, 48088
        • Valeant Site 16
    • Minnesota
      • Fridley, Minnesota, United States, 55421
        • Valeant Site 18
    • Nebraska
      • Omaha, Nebraska, United States, 68022
        • Valeant Site 31
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Valeant Site 2
    • New York
      • New York, New York, United States, 10001
        • Valeant Site 29
      • Rochester, New York, United States, 14603
        • Valeant Site 39
    • Oregon
      • Portland, Oregon, United States, 97201
        • Valeant Site 5
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19019
        • Valeant Site 11
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Valeant Site 30
    • Tennessee
      • Nashville, Tennessee, United States, 37115
        • Valeant Site 15
    • Texas
      • Dallas, Texas, United States, 75201
        • Valeant Site 9
      • Houston, Texas, United States, 77001
        • Valeant Site 40
      • Houston, Texas, United States, 77004
        • Valeant Site 8
      • Katy, Texas, United States, 77449
        • Valeant Site 46
      • Pflugerville, Texas, United States, 78660
        • Valeant Site 20
      • San Antonio, Texas, United States, 78201
        • Valeant Site 21
      • San Antonio, Texas, United States, 78202
        • Valeant Site 7
      • Webster, Texas, United States, 77598
        • Valeant Site 22
    • Utah
      • Salt Lake City, Utah, United States, 84101
        • Valeant Site 38
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Valeant Site 23
      • Norfolk, Virginia, United States, 23501
        • Valeant Site 26
    • Washington
      • Spokane, Washington, United States, 99201
        • Valeant Site 42

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 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.
  • Has an area of plaque psoriasis appropriate for topical treatment that covers a Body Surface Area (BSA) of at least 3 percent (%), 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 Investigators Global Assessment (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 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IDP-118 Lotion
IDP-118 lotion (halobetasol propionate 0.01%, tazarotene 0.045%) will be applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
Drug: IDP-118 Lotion
IDP-118 lotion will be applied as per the instructions provided by the investigational center staff.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Experienced Grade 3 Local Skin Reactions
Time Frame: Baseline up to Week 52
Local skin reactions (itching, dryness, burning/stinging) graded at a level of 3 (severe) at any point in the study following the first application of study drug were assessed. Severe Itching (as reported by the participant within the last 24 hours) referred to the intense itching that may interrupt daily activities and/or sleep. Severe dryness (as assessed by the investigator) referred to as marked roughness of the skin. Severe burning/stinging (as reported by the participant within the last 24 hours) referred to as hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Baseline up to Week 52

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bausch Health Americas, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dow Pharmaceutical Sciences

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 24, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V01-118A-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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