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Trial record 7 of 8 for:    IDP 118

Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02785172
Recruitment Status : Completed
First Posted : May 27, 2016
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

Brief Summary:
Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque Psoriasis

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

Detailed Description:
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque Psoriasis

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis
Actual Study Start Date : April 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

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: Ultravate Cream
Cream
Drug: Ultravate Cream
Cream
Other Name: Ultravate

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

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




Primary Outcome Measures :
  1. Percent of subjects with treatment success [ Time Frame: 2 weeks ]
    Percent of subjects with treatment success, defined by at least a 2 grade improvement from Baseline in the IGA (Investigators Global Assessment) 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:   Yes
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 (Body Surface Area) 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 (Investigators 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.)
  • If female and of childbearing potential, must have a negative urine and serum pregnancy test at the Screening visit and negative urine pregnancy at Baseline visit prior to randomization.
  • Subject is willing to comply with study instructions and return to the clinic for required visits.

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): NCT02785172


Locations
United States, California
Valeant Site 12
Fullerton, California, United States, 92831
Valeant Site 04
La Mesa, California, United States, 91941
Valeant Site 03
San Diego, California, United States, 92093
Valeant Site 09
San Diego, California, United States, 92093
United States, Florida
Valeant Site 05
Lauderdale Lakes, Florida, United States, 33313
Valeant Site 02
Miami, Florida, United States, 33111
United States, Minnesota
Valeant Site 07
Fridley, Minnesota, United States, 55421
United States, North Carolina
Valeant Site 08
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Valeant Site 06
Columbus, Ohio, United States, 43085
United States, South Carolina
Valeant Site 13
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Valeant Site 11
Katy, Texas, United States, 77449
Valeant Site 10
San Antonio, Texas, United States, 78201
Valeant Site 01
Sugar Land, Texas, United States, 77479
United States, Utah
Valeant Site 14
Salt Lake City, Utah, United States, 84103
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Binu J Alexander, MD Valeant Pharmaceuticals
Study Director: Binu Alexander Valeant Pharmaceuticals

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT02785172     History of Changes
Other Study ID Numbers: V01-118A-203
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Halobetasol
Clobetasol
Vasoconstrictor Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs