Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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: NCT02045277
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : December 15, 2017
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 Monad HP Lotion Drug: IDP-118 Monad Taz Lotion Drug: IDP-118 Vehicle Lotion Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis
Study Start Date : February 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: IDP-118 Lotion
halobetasol propionate [HP], tazarotene [Taz]
Drug: IDP-118 Lotion
Lotion
Other Name: Lotion

Active Comparator: IDP-118 Monad HP Lotion
HP
Drug: IDP-118 Monad HP Lotion
Active Comparator
Other Name: HP

Active Comparator: IDP-118 Monad Taz Lotion
Taz
Drug: IDP-118 Monad Taz Lotion
Active Comparator
Other Name: Taz

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




Primary Outcome Measures :
  1. The percent of subjects with treatment success [ Time Frame: 12 weeks ]
    defined as at least a 2 grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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, 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 ClinicalTrials.gov identifier (NCT number): NCT02045277


Locations
Layout table for location information
United States, California
Valeant Site 13
Encino, California, United States, 91436
Valeant Site 11
San Diego, California, United States, 92123
Valeant Site 15
Santa Rosa, California, United States, 95403
United States, Georgia
Valeant Site 10
Augusta, Georgia, United States, 30909
Valeant Site 09
Newnan, Georgia, United States, 30263
United States, Kentucky
Valeant Site 08
Louisville, Kentucky, United States, 40217
United States, Maryland
Valeant Site 04
Rockville, Maryland, United States, 20850
United States, Michigan
Valeant Site 14
Clinton Township, Michigan, United States, 48038
United States, Minnesota
Valeant Site 07
Fridley, Minnesota, United States, 55432
United States, New Jersey
Valeant Site 01
East Windsor, New Jersey, United States, 08520
United States, New York
Valeant Site 03
New York, New York, United States, 10075
Valeant Site 17
Rochester, New York, United States, 14623
United States, North Carolina
Valeant Site 02
High Point, North Carolina, United States, 27262
United States, Texas
Valeant Site 05
Austin, Texas, United States, 78759
Valeant Site 06
College Station, Texas, United States, 77845
United States, Utah
Valeant Site 16
Salt Lake City, Utah, United States, 84117
United States, Virginia
Valeant Site 18
Lynchburg, Virginia, United States, 24501
Valeant Site 12
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Bausch Health Americas, Inc.
Dow Pharmaceutical Sciences
Investigators
Layout table for investigator information
Study Director: Binu J Alexander Valeant Pharmaceuticals

Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02045277     History of Changes
Other Study ID Numbers: V01-118A-201
First Posted: January 24, 2014    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:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases