Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis

A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis

The objective of the study is to evaluate the safety and efficacy of a topical lotion

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: IDP-118 Lotion; Drug: IDP-118 Monad HP Lotion; Drug: IDP-118 Monad Taz Lotion; Drug: IDP-118 Vehicle Lotion

Detailed Description

The objective of the study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult subjects with moderate to severe plaque psoriasis.

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91436
      • Valeant Site 13
    • San Diego, California, United States, 92123
      • Valeant Site 11
    • Santa Rosa, California, United States, 95403
      • Valeant Site 15
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Valeant Site 10
    • Newnan, Georgia, United States, 30263
      • Valeant Site 09
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Valeant Site 08
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Valeant Site 04
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Valeant Site 14
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Valeant Site 07
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Valeant Site 01
  • New York
    • New York, New York, United States, 10075
      • Valeant Site 03
    • Rochester, New York, United States, 14623
      • Valeant Site 17
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Valeant Site 02
  • Texas
    • Austin, Texas, United States, 78759
      • Valeant Site 05
    • College Station, Texas, United States, 77845
      • Valeant Site 06
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Valeant Site 16
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Valeant Site 18
    • Norfolk, Virginia, United States, 23507
      • Valeant Site 12

Participation Criteria

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.
• Has an area of plaque psoriasis appropriate for topical treatment that covers a 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, if psoriasis is present).

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: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDP-118 Lotion; halobetasol propionate [HP], tazarotene [Taz]	Drug: IDP-118 Lotion; Lotion; Other Names: Lotion
Active Comparator: IDP-118 Monad HP Lotion; HP	Drug: IDP-118 Monad HP Lotion; Active Comparator; Other Names: HP
Active Comparator: IDP-118 Monad Taz Lotion; Taz	Drug: IDP-118 Monad Taz Lotion; Active Comparator; Other Names: Taz
Active Comparator: IDP-118 Vehicle Lotion; Vehicle	Drug: IDP-118 Vehicle Lotion; Vehicle; Other Names: Vehicle

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 8	Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. 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).	8 weeks
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 Weeks 2, 4, 6, and 12	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 Weeks 2, 4, 6, and 12. 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).	Weeks 2, 4, 6, and 12 (4-week follow-up)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: January 22, 2014
• First Submitted That Met QC Criteria: January 22, 2014
• First Posted (Estimate): January 24, 2014

Study Record Updates

• Last Update Posted (Actual): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 8, 2020
• Last Verified: August 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-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes