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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02462122
Recruitment Status : Completed
First Posted : June 3, 2015
Results First Posted : August 20, 2020
Last Update Posted : August 20, 2020
Sponsor:
Collaborator:
Dow Pharmaceutical Sciences
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Description
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Brief Summary:
Safety and Efficacy of IDP-118 in the treatment of plaque psoriasis

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

Detailed Description:
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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 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 19, 2015
Actual Primary Completion Date : November 9, 2016
Actual Study Completion Date : November 14, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462122


Locations
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United States, California
Valeant Site 5
Fremont, California, United States, 94536
United States, Florida
Valeant Site 2
Boynton Beach, Florida, United States, 33424
Valeant Site 14
North Miami Beach, Florida, United States, 33160
United States, Michigan
Valeant Site 13
Detroit, Michigan, United States, 48201
Valeant Site 8
Warren, Michigan, United States, 48088
United States, Minnesota
Valeant Site 10
Fridley, Minnesota, United States, 55421
United States, New Jersey
Valeant Site 1
East Windsor, New Jersey, United States, 08520
United States, New Mexico
Valeant Site 4
Albuquerque, New Mexico, United States, 87103
United States, New York
Valeant Site 12
New York, New York, United States, 10001
United States, North Carolina
Valeant Site 6
High Point, North Carolina, United States, 27260
United States, Oregon
Valeant Site 3
Portland, Oregon, United States, 97201
United States, Tennessee
Valeant Site 7
Knoxville, Tennessee, United States, 37909
United States, Texas
Valeant Site 9
College Station, Texas, United States, 77840
Valeant Site 15
Houston, Texas, United States, 77001
Valeant Site 16
Houston, Texas, United States, 77001
Valeant Site 11
Pflugerville, Texas, United States, 78660
Sponsors and Collaborators
Bausch Health Americas, Inc.
Dow Pharmaceutical Sciences
Investigators
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Study Director: Binu J Alexander, MD Valeant Pharmaceuticals
More Information
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02462122    
Obsolete Identifiers: NCT02615093
Other Study ID Numbers: V01-118A-302
First Posted: June 3, 2015    Key Record Dates
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:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases