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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: NCT02462070
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : December 2, 2019
Sponsor:
Collaborator:
Dow Pharmaceutical Sciences
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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




Primary Outcome Measures :
  1. The percent of subjects with treatment success [ Time Frame: 3 months ]
    Defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear".



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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.

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): NCT02462070


Locations
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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
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Study Director: Binu J Alexander Valeant Pharmaceuticals

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02462070     History of Changes
Other Study ID Numbers: V01-118A-301
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
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