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Trial record 44 of 51 for:    tazarotene

Safety and Efficacy of IDP-118 Lotion 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. Identifier: NCT02785159
Recruitment Status : Completed
First Posted : May 27, 2016
Last Update Posted : December 15, 2017
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: IDP-118 Lotion Drug: Tazorac Cream Drug: IDP-118 Vehicle Lotion Drug: IDP-118 Vehicle Cream Phase 2

Detailed Description:
A Phase 2, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Double Blinded, Randomized, Vehicle Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Study Start Date : February 2016
Actual Primary Completion Date : November 20, 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Tazarotene

Arm Intervention/treatment
Experimental: IDP-118 Lotion
Drug: IDP-118 Lotion
Other Name: Lotion

Active Comparator: Tazorac Cream
Drug: Tazorac Cream
Other Name: Tazorac

Active Comparator: IDP 118 Vehicle Lotion
Drug: IDP-118 Vehicle Lotion
Other Name: Vehicle

Active Comparator: IDP-118 Vehicle Cream
Drug: IDP-118 Vehicle Cream
Other Name: Vehicle

Primary Outcome Measures :
  1. 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. [ Time Frame: 12 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT02785159

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United States, California
Valeant Site 12
Encino, California, United States, 91316
United States, Florida
Valeant Site 13
Orange Park, Florida, United States, 32065
Valeant Site 11
Pinellas Park, Florida, United States, 33780
Valeant Site 01
Tampa, Florida, United States, 33601
Valeant Site 04
Tampa, Florida, United States, 33601
United States, Indiana
Valeant Site 05
Plainfield, Indiana, United States, 46168
United States, Michigan
Valeant Site 09
Clarkston, Michigan, United States, 48346
United States, Minnesota
Valeant Site 07
Fridley, Minnesota, United States, 55421
United States, Missouri
Valeant Site 14
Saint Joseph, Missouri, United States, 64501
United States, South Carolina
Valeant Site 10
Greenville, South Carolina, United States, 29601
United States, Tennessee
Valeant Site 03
Murfreesboro, Tennessee, United States, 37129
United States, Texas
Valeant Site 06
College Station, Texas, United States, 77840
Valeant Site 08
Webster, Texas, United States, 77598
United States, Virginia
Valeant Site 02
Charlottesville, Virginia, United States, 22901
Sponsors and Collaborators
Bausch Health Americas, Inc.
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Study Director: Binu J Alexander, MD Valeant Pharmaceuticals

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Responsible Party: Bausch Health Americas, Inc. Identifier: NCT02785159     History of Changes
Other Study ID Numbers: V01-118A-202
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents
Keratolytic Agents