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

A Phase 2, Multicenter, Double Blinded, Randomized, Vehicle Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion With Tazorac (Tazarotene) Cream, 0.05% in the Treatment of Plaque Psoriasis

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: IDP-118 Lotion; Drug: IDP-118 Vehicle Lotion; Drug: Tazorac Cream; Drug: IDP-118 Vehicle Cream

Detailed Description

A Phase 2, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion with Tazorac (tazarotene) Cream, 0.05% in the Treatment of Plaque Psoriasis

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91316
      • Valeant Site 12
  • Florida
    • Orange Park, Florida, United States, 32065
      • Valeant Site 13
    • Pinellas Park, Florida, United States, 33780
      • Valeant Site 11
    • Tampa, Florida, United States, 33601
      • Valeant Site 01
    • Tampa, Florida, United States, 33601
      • Valeant Site 04
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Valeant Site 05
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Valeant Site 09
  • Minnesota
    • Fridley, Minnesota, United States, 55421
      • Valeant Site 07
  • Missouri
    • Saint Joseph, Missouri, United States, 64501
      • Valeant Site 14
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • Valeant Site 10
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37129
      • Valeant Site 03
  • Texas
    • College Station, Texas, United States, 77840
      • Valeant Site 06
    • Webster, Texas, United States, 77598
      • Valeant Site 08
  • Virginia
    • Charlottesville, Virginia, United States, 22901
      • Valeant Site 02

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• 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%, 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) Investigator Global Assessment 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: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDP-118 Lotion; Lotion	Drug: IDP-118 Lotion; Lotion; Other Names: Lotion
Active Comparator: Tazorac Cream; Cream	Drug: Tazorac Cream; Cream; Other Names: Tazorac
Active Comparator: IDP 118 Vehicle Lotion; Lotion	Drug: IDP-118 Vehicle Lotion; Lotion; Other Names: Vehicle
Active Comparator: IDP-118 Vehicle Cream; Cream	Drug: IDP-118 Vehicle Cream; Cream; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Subjects With Treatment Success, Defined by at Least a 2 Grade Improvement From Baseline in the Investigator Global Assessment (IGA) Score Equating to Clear or Almost Clear.	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". 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).	12 Weeks

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: Binu J Alexander, MD, Valeant Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): November 20, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 27, 2016

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; Dermatologic Agents; Keratolytic Agents; Tazarotene
• Other Study ID Numbers: V01-118A-202

Plan for Individual participant data (IPD)

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