Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IDP-122 Lotion
IDP-122 Vehicle Lotion
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis
Eligibility 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.
Sites / Locations
- Valeant Site 14
- Valeant Site 02
- Valeant Site 10
- Valeant Site 1
- Valeant Site 07
- Valeant Site 15
- Valeant Site 08
- Valeant Site 13
- Valeant Site 04
- Valeant Site 12
- Valeant Site 05
- Valeant Site 11
- Valeant Site 03
- Valeant Site 09
- Valeant Site 06
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IDP-122 Lotion
IDP-122 Vehicle Lotion
Arm Description
Participants will apply IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks.
Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants With Treatment Success at 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
Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12
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.
Full Information
NCT ID
NCT02515097
First Posted
July 31, 2015
Last Updated
January 14, 2020
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02515097
Brief Title
Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2015 (Actual)
Primary Completion Date
March 15, 2017 (Actual)
Study Completion Date
March 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
213 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IDP-122 Lotion
Arm Type
Experimental
Arm Description
Participants will apply IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks.
Arm Title
IDP-122 Vehicle Lotion
Arm Type
Placebo Comparator
Arm Description
Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
IDP-122 Lotion
Other Intervention Name(s)
HP 0.01%
Intervention Description
Medicated topical lotion
Intervention Type
Drug
Intervention Name(s)
IDP-122 Vehicle Lotion
Intervention Description
Vehicle topical lotion with no active ingredient
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment Success at Week 8
Description
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.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12
Description
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.
Time Frame
Weeks 2, 4, 6, and 12 (4-week follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binu J Alexander
Organizational Affiliation
Valeant Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Valeant Site 14
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Valeant Site 02
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33424
Country
United States
Facility Name
Valeant Site 10
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33755
Country
United States
Facility Name
Valeant Site 1
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Valeant Site 07
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Valeant Site 15
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66051
Country
United States
Facility Name
Valeant Site 08
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55421
Country
United States
Facility Name
Valeant Site 13
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68022
Country
United States
Facility Name
Valeant Site 04
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Valeant Site 12
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Valeant Site 05
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27260
Country
United States
Facility Name
Valeant Site 11
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
Valeant Site 03
City
Houston
State/Province
Texas
ZIP/Postal Code
77001
Country
United States
Facility Name
Valeant Site 09
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Valeant Site 06
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84081
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
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