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

• ClinicalTrials.gov Identifier: NCT02462070
• Recruitment Status: Completed
• First Posted: June 3, 2015
• Results First Posted: August 20, 2020
• Last Update Posted: August 20, 2020
• Sponsor: Bausch Health Americas, Inc.
• Collaborator: Dow Pharmaceutical Sciences
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Plaque Psoriasis	Drug: IDP-118 Lotion; Drug: IDP-118 Vehicle Lotion	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 203 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-118 in the Treatment of Plaque Psoriasis
• Actual Study Start Date: August 11, 2015
• Actual Primary Completion Date: November 8, 2016
• Actual Study Completion Date: December 1, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: IDP-118 Lotion; Lotion	Drug: IDP-118 Lotion; Lotion; Other Name: Lotion
Active Comparator: IDP-118 Vehicle Lotion; Vehicle Lotion	Drug: IDP-118 Vehicle Lotion; Lotion; Other Name: Vehicle

Outcome Measures

Primary Outcome Measures :

1. The Percentage of Participants With Treatment Success at Week 8 [ Time Frame: 8 weeks ]
   Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.

Secondary Outcome Measures :

1. Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 [ Time Frame: 12 weeks ]
   Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.

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 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).

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, Alabama

Valeant Site 3

Mobile, Alabama, United States, 36601

United States, California

Valeant Site 9

Beverly Hills, California, United States, 90210

Valeant Site 12

Encino, California, United States, 91316

Valeant Site 10

San Diego, California, United States, 92093

Valeant Site 1

Santa Rosa, California, United States, 95403

United States, Colorado

Valeant Site 16

Denver, Colorado, United States, 80123

United States, Florida

Valeant Site 2

Tampa, Florida, United States, 33601

United States, Indiana

Valeant Site 7

South Bend, Indiana, United States, 46601

United States, Kentucky

Valeant Site 8

Louisville, Kentucky, United States, 40202

United States, Michigan

Valeant Site 13

Clinton Township, Michigan, United States, 48036

United States, New York

Valeant Site 14

Rochester, New York, United States, 14603

United States, Tennessee

Valeant Site 6

Nashville, Tennessee, United States, 37115

United States, Texas

Valeant Site 5

Austin, Texas, United States, 73344

Valeant Site 4

Houston, Texas, United States, 77001

United States, Virginia

Valeant Site 11

Norfolk, Virginia, United States, 23501

United States, Washington

Valeant Site 15

Spokane, Washington, United States, 99201

Sponsors and Collaborators

Bausch Health Americas, Inc.

Dow Pharmaceutical Sciences

Investigators

• Study Director: Binu J Alexander; Valeant Pharmaceuticals

More Information

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT02462070
• Other Study ID Numbers: V01-118A-301
• First Posted: June 3, 2015
• Results First Posted: August 20, 2020
• Last Update Posted: August 20, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases