Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis

• ClinicalTrials.gov Identifier: NCT02514577
• Recruitment Status: Completed
• First Posted: August 3, 2015
• Results First Posted: January 27, 2020
• Last Update Posted: January 27, 2020
• Sponsor: Bausch Health Americas, Inc.
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

Study Description

Brief Summary:

This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment [IGA] score of 3 or 4).

Condition or disease	Intervention/treatment	Phase
Plaque Psoriasis	Drug: IDP-122 Lotion; Drug: IDP-122 Vehicle Lotion	Phase 3

Detailed Description:

This study is a multicenter, double-blind, randomized, parallel-group study designed to assess the safety and efficacy of IDP-122 Lotion in comparison with its vehicle. To be eligible for the study, participants must be at least 18 years of age and have a clinical diagnosis of moderate to severe psoriasis (defined as an IGA score of 3 or 4).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 217 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-122 in the Treatment of Plaque Psoriasis
• Actual Study Start Date: November 7, 2015
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: IDP-122 Lotion; Participants will apply IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks.	Drug: IDP-122 Lotion; Topical lotion; Other Name: HP 0.01%
Active Comparator: IDP-122 Vehicle Lotion; Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks.	Drug: IDP-122 Vehicle Lotion; Topical lotion. No active ingredient.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Treatment Success at Week 8 [ Time Frame: 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). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.

Secondary Outcome Measures :

1. Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 [ Time Frame: Weeks 2, 4, 6, and 12 (4-week follow-up) ]
   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). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 score of 3 or 4 (the face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded from this calculation, 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.

Contacts and Locations

Locations

United States, Arkansas

Valeant Site 11

Hot Springs, Arkansas, United States, 71901

United States, California

Valeant Site 1

Encinitas, California, United States, 92023

Valeant Site 10

Encino, California, United States, 91436

Valeant Site 12

Santa Rosa, California, United States, 95401

United States, Georgia

Valeant Site 13

Atlanta, Georgia, United States, 30301

United States, Idaho

Valeant Site 7

Boise, Idaho, United States, 83701

United States, Maryland

Valeant Site 6

Rockville, Maryland, United States, 20847

United States, Michigan

Valeant Site 4

Ann Arbor, Michigan, United States, 48103

Valeant Site 8

Clarkston, Michigan, United States, 48346

United States, Nevada

Valeant Site 15

Las Vegas, Nevada, United States, 89101

United States, North Carolina

Valeant Site 9

Raleigh, North Carolina, United States, 27601

United States, Tennessee

Valeant Site 5

Knoxville, Tennessee, United States, 37901

United States, Texas

Valeant Site 3

Austin, Texas, United States, 73301

Valeant Site 2

San Antonio, Texas, United States, 78201

United States, Washington

Valeant Site 14

Spokane, Washington, United States, 99201

Sponsors and Collaborators

Bausch Health Americas, Inc.

Investigators

• Study Director: Binu j Alexander; Valeant Pharmaceuticals

  Study Documents (Full-Text)

Documents provided by Bausch Health Americas, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] October 14, 2015

More Information

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT02514577
• Other Study ID Numbers: V01-122A-301
• First Posted: August 3, 2015
• Results First Posted: January 27, 2020
• Last Update Posted: January 27, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases