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

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: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: IDP-118 Lotion

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: Interventional
• Enrollment (Actual): 555
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Experienced Grade 3 Local Skin Reactions	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

• Sponsor: Bausch Health Americas, Inc.
• Collaborators: Dow Pharmaceutical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2015
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): April 24, 2017

Study Registration Dates

• First Submitted: June 1, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimate): June 3, 2015

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: V01-118A-303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO