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Safety and Efficacy of IDP-122 in the Treatment of Participants With 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: NCT02515097
Recruitment Status : Completed
First Posted : August 4, 2015
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:
This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment [IGA] score of 3 or 4).

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: IDP-122 Lotion Drug: IDP-122 Vehicle Lotion Phase 3

Detailed Description:
The objective of the study is to evaluate the safety and efficacy of topical IDP-122 Lotion when applied once daily to adult participants with moderate to severe plaque psoriasis. The intent of the study is specifically to evaluate the safety and efficacy of a once daily application of IDP-122 Lotion in comparison with vehicle.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 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-122 in the Treatment of Plaque Psoriasis
Actual Study Start Date : November 5, 2015
Actual Primary Completion Date : March 15, 2017
Actual Study Completion Date : March 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: IDP-122 Lotion
Participants will apply IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks.
Drug: IDP-122 Lotion
Medicated topical lotion
Other Name: HP 0.01%

Placebo Comparator: IDP-122 Vehicle Lotion
Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks.
Drug: IDP-122 Vehicle Lotion
Vehicle topical lotion with no active ingredient




Primary Outcome Measures :
  1. Percentage of Participants With Treatment Success at Week 8 [ Time Frame: Week 8 ]
    Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.


Secondary Outcome Measures :
  1. Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 [ Time Frame: Weeks 2, 4, 6, and 12 (4-week follow-up) ]
    Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Weeks 2, 4, 6, and 12. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.



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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

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 score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).

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): NCT02515097


Locations
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United States, California
Valeant Site 14
Santa Ana, California, United States, 92701
United States, Florida
Valeant Site 02
Boynton Beach, Florida, United States, 33424
Valeant Site 10
Clearwater, Florida, United States, 33755
Valeant Site 1
Tampa, Florida, United States, 33603
United States, Indiana
Valeant Site 07
Plainfield, Indiana, United States, 46168
United States, Kansas
Valeant Site 15
Olathe, Kansas, United States, 66051
United States, Minnesota
Valeant Site 08
Fridley, Minnesota, United States, 55421
United States, Nebraska
Valeant Site 13
Omaha, Nebraska, United States, 68022
United States, New York
Valeant Site 04
New York, New York, United States, 10001
Valeant Site 12
Stony Brook, New York, United States, 11790
United States, North Carolina
Valeant Site 05
High Point, North Carolina, United States, 27260
United States, Tennessee
Valeant Site 11
Knoxville, Tennessee, United States, 37901
United States, Texas
Valeant Site 03
Houston, Texas, United States, 77001
Valeant Site 09
San Antonio, Texas, United States, 78201
United States, Utah
Valeant Site 06
West Jordan, Utah, United States, 84081
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Binu J Alexander Valeant Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Bausch Health Americas, Inc.:
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02515097    
Other Study ID Numbers: V01-122A-302
First Posted: August 4, 2015    Key Record Dates
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases